BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 1921183 · Received December 13, 2010

    Report

    Report Number
    3005075853-2010-07032
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 26, 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). THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED FOR CONTINUITY AND WAS FOUND TO BE CONFORMING. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE COULD NOT BE ACTIVATED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1