BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3241748 · Received July 22, 2013

    Report

    Report Number
    2955842-2013-02687
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS 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.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED (B)(4). THE EVENT DETAILS ARE PROVIDED BELOW: CABLE BREAK NOTED DURING PRE-OP INSPECTION. ITEM NOT USED. NO HARM TO PATIENT. THIS ITEM HAD 10 USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341578 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10120615 191

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU