FDA Adverse Event Malfunction Summary report: N

LARGE NEEDLE DRIVER INSTRUMENT

MDR report key: 2871143 · Received December 12, 2012

Report

Report Number: 2955842-2012-01288
Event Type: Malfunction
Date Received: December 12, 2012
Date of Event: October 26, 2012
Report Date: November 14, 2012
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED FOR EVALUATION. COMPLAINT OF REPROCESSING ISSUE CANNOT BE CONFIRMED. VISUAL INSPECTION OF GRIPS/WRIST ASSEMBLY WITH NO MAGNIFICATION SHOWS NO OBVIOUS DAMAGE. INSTRUMENT HEAD SHOWS NO DAMAGE BESIDES NORMAL WEAR AND TEAR. HOWEVER, WE FOUND SCRATCHES ON MAINTUBE. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SUGGESTING IT MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. 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

ON (B)(6) 2012 THE LARGE NEEDLE DRIVER INSTRUMENT WAS RETURNED INDICATING THEY HAD A STERILIZATION ISSUE. THE PRODUCT WAS EVALUATED BY THE FAILURE ANALYSIS TEAM. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LARGE NEEDLE DRIVER INSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420006-06	M12120215 130

Patients

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