BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 1831948 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05188
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 19, 2010
    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). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, ALTHOUGH THE ACTUATION SOUND WAS HEARD, THE DEVICE COULD NOT BE ACTIVATED ON THE TISSUE WHEN THE HAND SWITCH WAS PUSHED. THEN THE HAND SWITCH WAS CHANGED, BUT THE EVENT CONTINUED. ANOTHER NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGERY PROBE PLUS II LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK G4T162

    Patients

    Seq Age Sex Outcome Treatment
    1