FDA Adverse Event Malfunction Summary report: N

PROGRASP FORCEPS INSTRUMENT

MDR report key: 3842294 · Received June 1, 2014

Report

Report Number: 2955842-2014-03347
Event Type: Malfunction
Date Received: June 1, 2014
Date of Event: May 7, 2014
Report Date: May 7, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: RI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE PITCH UP CABLE WAS FOUND TO BE FRAYED AT THE DISTAL CLEVIS HUB. A SMALL FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE UNDAMAGED AND CLEVIS SHOWED NO DAMAGE. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .265 - .149 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S PITCH UP AND/OR MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING REPROCESSING OF THE PROGRASP FORCEPS INSTRUMENT, IT WAS NOTED THAT THE CABLE ON THE INSTRUMENT WAS FRAYED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
320701	PROGRASP FORCEPS INSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420093-10	M10131024 179

Patients

Seq	Age	Sex	Outcome	Treatment
1