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Medium RiskFDA Device

CooperSurgical, Inc.: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.; XXX

Agency Publication Date: November 18, 2021
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Affected Products

Product: LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120

Serial Numbers: Lot/Serial Number 0115001 0115001 0115001 0115002 0115003 0115004 0115005 0115005 0115006 0115007 0115007 0115008 0115009 0115010 0115011 0115012 0115012 0115013 0115014 0115015 0115015 0115016 0115017 0115018 0115019 0115020 0115021 0115022 0115023 0115024 0115025 0115026 0115027 0115028 0115029 0115030 0115031 0115032 0115033 0115034 0115035 0115036 0115037 0115038 0115039 0115040 0215001 0215003 0215004 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215019 0215020 0215021 1114001 1114002 1114003 1114004 1114005 1114006 1114007 1114008 1114009 1114010 1114011 1114012 1114013 1114013 1114014 1114015 1114016 1114017 1114018 1114019 1114020 1114021 1114022 1114023 1114024 1114025 1114026 1114027 1114028 1214001 1214002 1214003 1214004 1214005 1214005 1214006 1214007 2015060001 2015060002 2015060003 2015060004 2015060004 2015060005 2015060006 2015060007 2015060008 2015060009 2015060010 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2021030022 2021030023 2021030024 2021030025 2021030026 2021030027 2021030028 2021030029 2021030030 2021030031 2021030032 2021030033 2021030034 2021030035 2021030036 2021030037 2021030038 2021030039 2021030040 2021040001 2021040002 2021040003 2021040004 2021040005 2021040006 2021040007 2021040008 2021040009 2021040010 2021040011 2021040012 2021040013 2021040014 2021040015 2021040016 2021040017 2021040018 2021040019 2021040020 2021040023 2021040024 2021040025 2021040026 2021040027 2021040028 2021040029 2021040030 2021040031 2021040032 2021040033 2021040034 2021040035 2021040036 2021040037 2021040038 2021040039 2021040040 2021040041 2021040042 2021040043 2021040043 2021040044 2021040045 2021040046 2021040047 2021040049 2021040050 2021040051 2021040052 2021040053 2021040054 2021040055 2021050001 2021050002 2021050003 2021050004 2021050005 2021050006 2021050007 2021050008 2021050009 2021050010 2021050011 2021050012 2021050013 2021050014 2021050015 2021050016 2021050017 2021060003 2021060004 2021060005 2021060006 2021060009 2021060010 2021060011 2021060013 2021060019 2021060022 2021060023 2021060024 2021060025 2021060026 2021060027 2021060028

Product: LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

Serial Numbers: 2017040001 2017040002 2017040003 2017040004 2017040005 2018030001 2018030002 2018030003 2018030004 2018100004 2018100005 2018100006 2018120001 2018120002 2018120003 2019010001 2019010002 2019010003 2019010004 2019010005 2019030001 2019030002 2019030003 2019030004 2019070001 2019070002 2019070003 2019070004 2019070005 2019070006 2019100001 2019100004 2019100005 2019120001 2019120002 2019120003 2019120004 2019120005 2019120006 2020030001 2020030002 2020030003 2020030004 2020030005 2020060001 2020060002 2020060003 2020060004 2020060005 2020060006 2020080001 2020080002 2020080003 2020080004 2020080005 2020080006 2020110001 2020110002 2020110003 2020110004 2020110005 2020110006 2020120001 2020120002 2020120003 2020120004 2020120005 2020120006 2021010001 2021010002 2021010003 2021010004 2021010005

Product: LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120

Serial Numbers: 0215002 1214007 2015050001 2016060030 2016060031 2016070002 2016070004 2016070012 2016070017 2016070021 2016070022 2016070026 2016070027 2016070028 2016070030 2016070031 2016080002 2016080004 2016080007 2016080009 2016080015 2016080016 2016080017 2016080018 2016080019 2016080020 2016080021 2016080022 2016080025 2016080026 2016080027 2016080029 2016080031 2016080033 2016080034 2016080035 2016080036 2016100002 2016100004 2016100009 2016100010 2016100012 2016100013 2016100014 2016100016 2016100017 2016100018 2016100021 2016100023 2016100024 2016100025 2016100027 2016100028 2015050016 2015050017 2015050018 2015050019 2015050020 2015110007 2016030001 2016030002 2016030006 2016030007 2016030013 2016030015 2016040001 2016040002 2016040004 2016040006 2016040007 2016040010 2016050004 2016050006 2016050007 2016050010 2016050012 2016050013 2016050015 2016050016 2016050019 2016050029 2016050031 2016050034 2016060001 2016060002 2016060003 2016060004 2016060006 2016060007 2016060009 2016060012 2016060013 2016060016 2016060021 2016060022 2016060023 2016060025 2016060026 2016060028 2016060029 2016100029 2016100033 2016100034 2016100035 2016120002 2016120003 2016120004 2016120005 2016120008 2016120010 2016120011 2017010001 2017010002 2017010003 2017010004 2017010005 2017010006 2017010007 2017010009 2017010010 2017010011 2017010012 2017010015 2017010016 2017010018 2017010020 2017010023 2017020001 2017020002 2017020003 2017020004 2017020005 2017020006 2017020008 2017020011 2017020012 2017020013 2017020014 2017020017 2017020019 2017040001 2017040002 2017040003 2017040005 2017040008 2017040015 2017050008 2017050012 2017050013 2017050014 2017050015 2017050016 2017050017 2017060003 2017060004 2017060006 2017060010 2017060011 2017060012 2017060013 2017060014 2017060015 2017070002 2017070003 2017070005 2017070006 2017070009 2017070010 2017070012 2017070013 2017070015 2017080001 2017080003 2017080004 2017080005 2017080007 2017080010 2017080011 2017080015 2017090001 2017090003 2017090006 2017090009 2017090010 2017090014 2017110010 2017110012 2017110013 2017110015 2017110016 2017110017 2017110019 2017110026 2017110027 2017110028 2018100043 2019080030 2019080051 2019080052 2019100001 2019100002 2019100003 2019100017 2019100018 2019100019 2019100020 2020030021 2020040001 2020040002 2020040003 2020040004 2020070021 2020070022 2020070023 2020070024 2020070025 2020120001 2021010002 2021010003 2021010004 2021030041 2021030042 2021030043 2021030044 2021030045 2021040021 2021040022

Product: LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

Serial Numbers: 2018100001 2018100002 2018100003

Product: Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075

Serial Numbers: 0112010 0209001 0214002 0309031 0313007BFIX 0411002 0609010FIX 0710001 0711008 0713011C 0809009 0813032CFIX 091402 1013009C 1013015C 1109017 1214005 2015090019 2015110003 2016030001 2016040012 2016060016 2016090003 2016110002 2017010005 2017060010 2017080010 QTMAA-4-095 QTM-AB-10-149 QTM-M-4-102FIX W110954 W351106 W60413 0114011 0212004 0214007 0312021 0313010B 0413003B 0612001B 0710003 0711008FIX 0713018C 0811017 0813033C 1011010 1013010C 1014004 1111002 2015040009 2015090021 2015110004 2016030002 2016040015 2016060020 2016090004 2016110003 2017020004 2017060013 AFZFIX QTMAA4101 QTM-AB-12-164 QTMY-11-0201 W204996 W381180 W605041 0114013 0212008 0214008 0312024 0313011B 0511002 0612003B 0710008 0711009 0714007 0811021 0813034C 1011010FIX 1013011C 1109008 1213005C 2015060003 2015100004 2015110009 2016040001 2016040018 2016070003 2016090007 2016110004 2017030002 2017080002 ATM-AA-4-106 QTMAA-4-102 QTM-AB-12-165 QTMY-12-0208 W2A1022 W381192 W708311FIX 0115006 0212010 0215005 0312033 0409005 0511003 0612010B 0710008FIX 0712009B 0809004 0811021FIX 0814011FIX 1012006B 1013012C 1109014 1213006C 2015090012 2015100006FIX 2015110010 2016040002 2016060012 2016070007 2016090014 2016120002 2017030005 2017080003 GHILL QTMAA6116 QTMAB3067 QTMY70139 W2B1036 W604009 0115007 0214001 0215007 0313001B 0409006 0511003FIX 0612016B 0711006 0713001C 0809007 0813029C 0814012 1013006C 1013014C 1109015 1214003 2015090015 2015110001 2016020006 2016040007 2016060013 2016080002 2016110001 2017010002 2017030009 2017080006 IUY80207 QTMAA-6-116 QTM-AB-9135 W107893 W2C1054 W604013

Product: Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

Serial Numbers: 0209001 0209002 0209003 0209004 0211001 0211002 0211003 0211004 0211005 0211006 0211007 0211008 0211009 0211010 0211011 0211012 0211013 0211014 0211015 0211016 0211017 0211018 0211019 0211020 0211021 0211022 0211023 0211024 0211025 0211026 0211027 0211028 0211029 0211030 0211031 0211032 0211033 0211034 0211035 0211036 0211037 0211038 0211039 0211040 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215020 0215021 0215022 0215023 0215024 0215025 0215026 0215027 0215028 0215029 0215030 0215031 0215032 0215033 0215034 0215035 0215036 0314014 0314014KF 0314019 0410001 0410002 0410003 0410004 0410005 0410006 0410007 0410008 0410009 0410010 0410011 0410012 0410013 0410014 0410015 0410016 0410017 0410018 0410019 0410020 0410021 0410022 0410023 0410024 0410025 0410026 0410027 0410028 0410029 0410030 0410031 0410032 0410033 0410034 0410035 0410036 0410037 0410038 0410039 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Product: Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

Serial Numbers: 0111001 0111003 0111004 0111005 0111006 0112001 0112002 0112003 0113001B 0113002B 0113003B 0113004B 0113005B 0113006B 0113007B 0113008B 0113010B 0114001 0114002 0114003 0114004 0114005 0114006 0114007 0114008 0114009 0114010 0209015 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0312001 0312002 0312009 0312009FIX 0312010 0312028 0413001B 0414001 0414003 0414004 0414008 0414014 0414018 0512001B 0512002B 0513001B 0513002B 0513003B 0514005 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0712001B 0712002B 0712003B 0712004B 0712005B 0712006B 0713001C 0713002C 0713003C 0713004C 0713005C 0713006C 0809001SYC 0813020C 0813021C 0813022C 0813023C 0813024C 0813025C 0814010 1012001B 1012002B 1012003B 1012004B 1012005B 1012006B 1012007B 1012008B 1012009B 1012010B 1109018 1109019 1113001C 1113002C 1113003C 1113004C 1113005C 1113006C 1113007C 1113008C 1113009C 1113010C 1213001 1213002 1213003 1214007 2015040001 2015040002 2015040003 2015040004 2015040005 2015050001 2015050002 2015060001 2015060002 2015060003 2015060004 2015060005 2015070004 2015090002 2015090003 2016050001 2016050005 2016070001 2016070002 2016070003 2016070004 2016070005 2016100001 2016100002 2016100003 2016100004 2016100005 2016100006 2016120002 2016120003 2016120004 2016120005 2016120006 2016120007 2016120008 2017060003 2017060005 QTM-AB-1-002 QTMAB-12-175

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88648
Status: Active
Manufacturer: CooperSurgical, Inc.
Manufactured In: United States
Units Affected: 7 products (1587 Units; 75 Units; 244 Units; 75 Units; 193 Units; 700 Units; 154 Units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.