FDA Adverse Event Malfunction Summary report: N

PK DISSECTING FORCEPS INSTRUMENT

MDR report key: 4242294 · Received November 11, 2014

Report

Report Number: 2955842-2014-05639
Event Type: Malfunction
Date Received: November 11, 2014
Date of Event: September 15, 2014
Report Date: October 14, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K061260
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS INSERTED ON THE BODY CAVITY AND VISUALIZED WITH CAMERA, IT WOULD NOT MOVE. THE INSTRUMENT WAS REMOVED AND NOTICED BROKEN WIRES AT JOINT. A NEW INSTRUMENT WAS RETRIEVED AND INSERTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
726548	PK DISSECTING FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420227-03	M10130627 576

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR