FDA Adverse Event Malfunction Summary report: N

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

MDR report key: 3790233 · Received May 5, 2014

Report

Report Number: 2955842-2014-02762
Event Type: Malfunction
Date Received: May 5, 2014
Date of Event: April 4, 2014
Report Date: April 29, 2014
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 AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND.

Additional Manufacturer Narrative · 1

THE INSTRUMENT HAS BEEN RETURNED FOR EVALUATION, HOWEVER, FAILURE ANALYSIS INVESTIGATION OF THE RETURNED AFFECTED PART IS NOT COMPLETE. AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER A DA VINCI PROSTATECTOMY PROCEDURE, THERE WAS VISIBLE DAMAGE TO A CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
266237	FENESTRATED BIPOLAR FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420205-05	M10131129 259

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR