BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 2945541 · Received February 6, 2013

    Report

    Report Number
    3005075853-2013-00506
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED FOR CONTINUITY AND PASSED ALL TESTING. THE INSTRUMENT WAS DISASSEMBLED AND THE SWITCH DOME WAS FOUND TO BE OFF CENTER. THIS COULD HAVE AFFECTED THE ACTIVATION OF THE INSTRUMENT. CONTINUOUS ACTIVATION WAS NOT CONFIRMED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE KEPT BEING ACTIVATED AFTER THE SURGEON RELEASED THE BUTTON THOUGH IT WAS ACTIVATED PROPERLY FOR 2 HOURS. THE DEVICE STOPPED USING AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50882 ELECTROSURGERY PROBE PLUS II LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1