BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2781668 · Received October 10, 2012

    Report

    Report Number
    2955842-2012-00528
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 6, 2012
    Report Date
    September 7, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K082497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT WIRE FOUND TO BE SNAPPED IS CONFIRMED. ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. CABLE SEGMENT STICKS OUT AT WRIST. ALSO CONDUCTOR WIRE IS BROKEN. ONE CONDUCTOR WIRE IS BROKEN AT THE YAW PULLEY EXIT. WIRE IS DETACHED FROM ITS CONNECTION AT THE GRIP. ELECTRICAL CONTINUITY FAILED. YAW PULLEY SHOWS NO SIGNS OF ARCING. ADDITIONALLY ENGINEERING OBSERVED SCRATCHES ON MAIN TUBE. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SUGGESTING THE DAMAGE MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: PROPER CARE AND HANDLING IS ESSENTIAL FOR SATISFACTORY PERFORMANCE OF SURGICAL INSTRUMENTS AND ACCESSORIES. EXAMINE THE INSTRUMENT OR ACCESSORY - INCLUDING ALL OF ITS COMPONENTS - THOROUGHLY BEFORE AND AFTER EACH USE. IF ANY ABNORMALITY IS FOUND, DO NOT USE IT. USE THE DEVICE FOR ITS INTENDED PURPOSE ONLY. HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE A DAMAGED CANNULA OR REDUCER. DAMAGED CANNULAE AND REDUCERS MAY ABRADE THE INSTRUMENT SHAFT AND GENERATE PARTICLES THAT MAY FALL INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE PK DISSECTING FORCEPS INSTRUMENT WAS REPORTING HAVING BROKEN CABLES. THE CUSTOMER DID NOT ALLEGE ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10111213 768

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYSTEM, INSTRUMENTS & ACCESSORIE