FDA Adverse Event Malfunction Summary report: N

SMALL CLIP APPLIER INSTRUMENT

MDR report key: 2841099 · Received November 20, 2012

Report

Report Number: 2955842-2012-01017
Event Type: Malfunction
Date Received: November 20, 2012
Date of Event: October 22, 2012
Report Date: October 22, 2012
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE CLIP APPLIER GRIP IS BROKEN AND WAS RETURNED WITH INSTRUMENT. THE BROKEN PIECE MEASURED APPROXIMATELY ABOUT 0.050 X 0.138. ENGINEERING CONCLUDED THAT THE DAMAGE IS LIKELY DUE TO THE APPLICATION OF FORCE WHILE TRYING TO INSTALL A CLIP. THE BROKE ANGLE CAN BE REPLICATED ON AN IN-HOUSE TEST INSTRUMENT OF THE SAME TYPE WHEN A APPLYING A LOAD ON THE FIXTURE THAT CONTAINS THE CLIPS DURING INSTALLATION OF A CLIP ONTO THE GRIPS. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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 INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING SET-UP OF A DA VINCI S SURGICAL PROCEDURE ONE OF THE TIPS ON THE SMALL CLIP APPLIER INSTRUMENT BROKE OFF AND SEPARATED FROM THE INSTRUMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SMALL CLIP APPLIER INSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420003-06	S10111003 033

Patients

Seq	Age	Sex	Outcome	Treatment
1				DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES