FDA Adverse Event Malfunction Summary report: N

PK DISSECTING FORCEPS INSTRUMENT

MDR report key: 3801087 · Received May 8, 2014

Report

Report Number: 2955842-2014-02880
Event Type: Malfunction
Date Received: May 8, 2014
Date of Event: April 7, 2014
Report Date: April 11, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K061260
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT TESTING. ADDITIONAL OBSERVATIONS NOT REPORTED WERE ONE CONDUCTOR WIRE WAS BROKEN AT THE YAW PULLEY EXIT. THE WIRE WAS DETACHED FROM ITS CONNECTION AT THE GRIP. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND FAILED. THE YAW PULLEY SHOWED NO SIGNS OF ARCING. THE YAW PULLEY WAS MISSING A PIECE OPPOSITE THE CONDUCTOR BREAK, ALLOWING THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN YAW. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE MISSING PIECE OF YAW PULLEY FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. NOTHING REPORTEDLY FELL INTO A PATIENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
277602	PK DISSECTING FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420227-03	M10100610 853

Patients

Seq	Age	Sex	Outcome	Treatment
1