FDA Adverse Event Malfunction Summary report: N

COBRA GRASPER INSTRUMENT

MDR report key: 1061788 · Received June 13, 2008

Report

Report Number: 2955842-2008-01063
Event Type: Malfunction
Date Received: June 13, 2008
Report Date: June 13, 2008
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: GCJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTS AND FOUND THAT THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ENGINEERING ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCHES. A COUPLE OF THE SCRATCHES ARE DEEP ENOUGH TO HAVE MATERIAL REMOVED. THE SCRATCHES ARE SHORT, NARROW AND NOT ALIGNED WITH THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY DUE TO INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE JAWS OF THE COBRA GRASPER INSTRUMENT STOPPED OPENING AND CLOSING, HOWEVER, THIS DID NOT CAUSE ANY DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COBRA GRASPER INSTRUMENT	ENDOSCOPIC INSTRUMENT	GCJ	INTUITIVE SURGICAL, INC.	420190-06	080111 667

Patients

Seq	Age	Sex	Outcome	Treatment
1				DA VINCI S SURGICAL SYSTEM\| ACCESSORIES\| INSTRUMENT