FDA Adverse Event Malfunction Summary report: N

LARGE NEEDLE DRIVER INSTRUMENT

MDR report key: 1133565 · Received August 22, 2008

Report

Report Number: 2955842-2008-01233
Event Type: Malfunction
Date Received: August 22, 2008
Report Date: August 22, 2008
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: GCJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THAT THE DISTAL END OF THE MAIN TUBE HAS A 1 INCH LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE MARKS ARE PARALLEL TO THE TUBE AXIS AND BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. ALSO OBSERVED WERE RANDOM SCRATCH MARKS THAT ARE NOT ALIGNED WITH THE TUBE AXIS AND WERE MOST LIKELY FROM INSTRUMENT COLLISIONS AND OR ROUGH HANDLING. 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 INSTRUMENT OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SHAFT OF THE LARGE NEEDLE DRIVER INSTRUMENT IS ROUGH AND SCRATCHED. NO ADD'L INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LARGE NEEDLE DRIVER INSTRUMENT	ENDOSCOPIC INSTRUMENT	GCJ	INTUITIVE SURGICAL, INC.	420006-04	1909072 475

Patients

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