Intuitive Surgical, Inc.: Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.; Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Agency Publication Date: November 25, 2014

Affected Products

Product: 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470001-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470006-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470033-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470171-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470093-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470172-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470179-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number: 470181-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number:470183-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number 470205-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470207-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470246-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470249-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470309-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470327-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470344-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Product: 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69638

Status: Resolved

Manufacturer: Intuitive Surgical, Inc.

Manufactured In: United States

Units Affected: 21 products (509 - total all affected instruments; 509 - total all affected instruments; 509 units - total all affected instruments; 509 units - total all affected devices; 509 Units, total all affected units; 5-9 units - total all devices; 509 total units - all affected devices; 509 Total Devices, all affected units; 509 total devices, all affected units; 509 total units - all affected devices; 509 total units, all affected devices; 509 total units - all affected devices; 509 total units, all affeced devices; 509 total units, all affected devices; 509 Total units, all affected devices; 509 Total units, all affected devices; 509 units, total all devices; 509 total units, all affected devices; 509 total units, all affected devices; 509 total units, all affected devices; 509 total units, all affected devices.)

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Affected Products