Medrobotics Corporation: The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

Agency Publication Date: April 17, 2019

Affected Products

Product: Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualiza

lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05

Product: Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualiza

lots 19419-01, 19669-06, 19684-06

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82403

Status: Resolved

Manufacturer: Medrobotics Corporation

Manufactured In: United States

Units Affected: 2 products (35; 24)

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Sources: FDA iRES · Raw API Response

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Affected Products

lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05

lots 19419-01, 19669-06, 19684-06