FDA Adverse Event Malfunction Summary report: N

PROGRASP FORCEPS INSTRUMENT

MDR report key: 3843914 · Received June 2, 2014

Report

Report Number: 2955842-2014-03366
Event Type: Malfunction
Date Received: June 2, 2014
Date of Event: March 27, 2014
Report Date: May 15, 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 OBSERVED THAT THE GRIP CABLE WAS FOUND TO BE DERAILED AT THE DISTAL CLEVIS HUB. THE YAW MOTION WAS NON-INTUITUVE AS A RESULT. THE HUB DID NOT EXHIBIT ANY WEAR. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S PITCH CABLES WAS BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE UNDAMAGED. 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 CABLE 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 A DA VINCI THYMECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE PROGRASP FORCEPS INSTRUMENT WAS FOUND DIFFICULT TO MOVE THE TIP OF THE INSTRUMENT. THE SURGERY WAS COMPLETED USING ANOTHER INSTRUMENT. 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
321428	PROGRASP FORCEPS INSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420093-11	M1013114 184

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR