FDA Adverse Event Malfunction Summary report: N

MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

MDR report key: 3870462 · Received June 12, 2014

Report

Report Number: 2955842-2014-03598
Event Type: Malfunction
Date Received: June 12, 2014
Date of Event: May 8, 2014
Report Date: May 16, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP CLOSE CABLE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY. THE CABLE SEGMENT STUCK OUT BETWEEN THE GRIPS MEASURING .445. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION NOT REPORTED BY WAS THE DISTAL IDLER PULLEY ON WHICH THE BROKEN CABLE WAS SEATED HAD INDENTATIONS ON THE EDGES. FAILURE ANALYSIS CONCLUDED THE PULLEY DAMAGE WAS LIKELY DUE TO MISHANDLING AND THIS DAMAGE LIKELY CONTRIBUTED TO CABLE BREAKAGE. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .232 - .177 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, WHILE SUTURING MESH INTO PLACE, THE CABLE BROKE SO THEY STOPPED USING THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
347782	MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420309-03	M10140215 099

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR