BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS

    MDR report key: 2803145 · Received October 24, 2012

    Report

    Report Number
    2955842-2012-00651
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 24, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED BROKEN WIRES, HOWEVER, FOR CLARIFICATION THE DAMAGED INSTRUMENT COMPONENT WAS A LOOSE PITCH CABLE. THE PITCH CABLE WAS FOUND LOOSE AT DISTAL CLEVIS HUB. BOTH CABLE CRIMPS REMAINED IN THE CLEVIS AND NO DAMAGE WAS FOUND ON CABLE. UPON HOUSING REMOVAL FOUND PITCH CABLE LOOSE AT CLAMPING PULLEY, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. ELECTRICAL CONTINUITY PASSED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROCEDURE, BROKEN WIRES WERE NOTED ON THE PK DISSECTING FORCEPS INSTRUMENT. 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 M10120417 608

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES