FDA Adverse Event Malfunction Summary report: N

MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

MDR report key: 2936120 · Received January 30, 2013

Report

Report Number: 2955842-2013-00318
Event Type: Malfunction
Date Received: January 30, 2013
Date of Event: December 27, 2012
Report Date: January 31, 2013
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ID
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLER PULLEY. THE IDLER PULLEY SPUN FREELYP; HOWEVER, IT HAD DAMAGES ON THE EDGE AND ON THE SURFACE. THE CABLE SEGMENT WAS STICKING OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE WIRES AT THE TIP OF THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT WERE OBSERVED TO BE BROKEN AND FRAYED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
40698	MEGASUTURECUT NEEDLE DRIVER INSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420309-01	M10120814 420

Patients

Seq	Age	Sex	Outcome	Treatment
1				DA VINCI S SURGICAL SYSTEM AND ACCESSORIES.