FDA Adverse Event Malfunction Summary report: N

BIPOLAR MARYLAND FORCEPS INSTRUMENT

MDR report key: 1061791 · Received June 13, 2008

Report

Report Number: 2955842-2008-01072
Event Type: Malfunction
Date Received: June 13, 2008
Report Date: June 13, 2008
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED TESTS AND FOUND THAT THE INSTRUMENT WAS SUCCESSFULLY RECOGNIZED THE SYSTEM. THE POGO PINS DO NOT STICK AND ARE NOT CONTAMINATED. THE INSTRUMENT WAS ABLE TO MOVE INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED AND CLOSED PROPERLY. ENGINEERING ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE WAS A 1.5 INCH LONG SECTION WITH LIGHT MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY PROCEDURE, SYSTEM WAS NOT RECOGNIZING THE BIPOLAR MARYLAND FORCEPS INSTRUMENT AND NOTHING FELL INTO THE PATIENT. 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	BIPOLAR MARYLAND FORCEPS INSTRUMENT	ELECTROSURGICAL INSTRUMENT	GEI	INTUITIVE SURGICAL, INC.	420172-06	1308071 943

Patients

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