FDA Adverse Event Malfunction Summary report: N

PK DISSECTING FORCEPS INSTRUMENT

MDR report key: 3942270 · Received July 17, 2014

Report

Report Number: 2955842-2014-04354
Event Type: Malfunction
Date Received: July 17, 2014
Date of Event: June 20, 2014
Report Date: July 9, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K061260
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE CONDUCTOR WIRE WAS BROKEN FROM THE SUB ASSEMBLY. THE YAW PULLEY WAS UNDAMAGED. THE CONDUCTOR CABLE WAS PLACED BACK IN THE SUB ASSEMBLY AND WAS ABLE TO FIT IN WITH NO TROUBLE. WHEN AT YAW MOTION THE CABLES STRETCHED AND BECAME DISLODGED AGAIN. THERE WAS NO MATERIAL MISSING OR DAMAGE TO THE CABLE. THE INSTRUMENT FAILED ELECTRICAL CONTINUITY TESTING. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .175 - .362 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS, 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 THE PK DISSECTING FORCEPS INSTRUMENT CABLE WAS NOTED TO BE BROKEN DURING REPROCESSING. NO FRAGMENTS FELL INTO THE PATIENT, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
419957	PK DISSECTING FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420227-03	M10131130 625

Patients

Seq	Age	Sex	Outcome	Treatment
1