BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS

    MDR report key: 2840758 · Received November 20, 2012

    Report

    Report Number
    2955842-2012-01004
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    February 8, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH THE GRIP CABLE BROKEN OFF AT THE DISTAL END. THE BROKEN CABLE SEGMENT STUCK OUT APPROXIMATELY .4720 AT THE WRIST BUT THERE WERE NO SIGNS OF DAMAGE WHERE THE CABLE BROKE OFF. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. ENGINEERING EVALUATION ALSO FOUND THAT THE CONDUCTOR WIRE WAS BROKEN AT THE DISTAL AND SEIZED BEARING. ONE CONDUCTOR WIRE WAS BROKEN AROUND THE SAME LOCATION AS THE GRIP CABLE. THE WIRE WAS DETACHED FROM ITS CONNECTION AT THE GRIP AND WAS STICKING OUT AT THE PROXIMAL END. THE INSTRUMENT ALSO PASSED ELECTRICAL CONTINUITY TESTING. THE DISTAL END DID NOT EXHIBIT ANY EVIDENCE OF ARCING. THE BEARING WHERE THE MAIN TUBE ENTERS THE CHASSIS WAS CORRODED AND NO LONGER ROTATED DURING ROLL. ENGINEERING CONCLUDED THAT THE DAMAGE TO THE BEARING WAS LIKELY RELATED TO CLEANING AND STERILIZATION. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES REPROCESSING INSTRUCTIONS SPECIFICALLY STATES: CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. WARNING: ENDOWRIST INSTRUMENTS, ACCESSORIES, AND ENDOSCOPES SHOULD BE HANDLED AND OPERATED BY TRAINED PERSONNEL. HANDLE WITH CARE. AVOID MECHANICAL ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED UF/IMPORTER REPORT (B)(4) FROM THE FDA. THE EVENT DETAILS ARE PROVIDED BELOW: DURING A ROBOTIC HYSTERECTOMY IT WAS NOTED THAT A WIRE AT THE TIP OF THE INSTRUMENT AT THE PULLEY SYSTEM WAS BROKEN. SURGEON DID NOT NOTE ANY UNUSUAL MOVEMENTS OR ISSUE HANDLING THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND/OR ACCESSORY HAVE NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION), OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE CABLE OF THE PK DISSECTING FORCEPS INSTRUMENT SNAPPED IN HALF. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120725 080

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES