BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABMEDICA

    MDR report key: 5486238 · Received March 8, 2016

    Report

    Report Number
    3006217371-2016-00004
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    January 12, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ABMEDICA SAS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED J HOOK INSTRUMENT WAS RETURNED TO THE MANUFACTURER AB MEDICA (B)(4). THE MANUFACTURER'S REPORT CONFIRMED THE RETURNED INSTRUMENT HAD BEEN REFURBISHED BY A THIRD PARTY PRIOR TO USE DURING THE REPORTED EVENT. THE SERIAL NUMBER OF THE RETURNED DEVICE COULD NOT BE IDENTIFIED DUE TO REFURBISHING. AN EVALUATION COULD NOT BE PERFORMED ON THE REFURBISHED DEVICE. A SAMPLE WAS TAKEN FROM THE SAME BATCH WHICH INCLUDED THE REPORTED SERIAL NUMBERS (B)(4). ELECTRICAL TESTS WERE PERFORMED ON THE INSULATION BY AN ACCREDITED LABORATORY AND FOUND THE INSULATION TO BE COMPLIANT UNDER NORMAL USE CONDITIONS.

    Description of Event or Problem · 1

    ON 2-10-2016, (B)(4) INITIAL IMPORTER AND DISTRIBUTOR FOR ABMEDICA (B)(4), BECAME AWARE OF AN ADVERSE EVENT THAT WAS PURPORTED TO HAVE OCCURRED AT A USER FACILITY, WHILE USING AN ABMEDICA MONOPOLAR J HOOK INSTRUMENT DURING A 40 MINUTE LAPAROSCOPIC CHOLECYSTECTOMY. THE EVENT WAS REPORTED TO (B)(4) BY THE USER FACILITY, (B)(6) SURGERY CENTER, WHO REPORTED THAT USE OF AN ABMEDICA MONOPOLAR J HOOK RESULTED IN A SKIN BURN TO THE PATIENT. THE DEGREE OF THE BURN AND EXACT LOCATION OF THE INJURY WAS NOT PROVIDED. HOWEVER, THE USER FACILITY INDICATED THAT "THE BURN WAS TREATED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED". THE ABMEDICA J HOOK WAS USED IN CONJUNCTION WITH A CONMED SABRE 600 GENERATOR AT SETTINGS OF CUT 35 AND COAG 50. THE SERIAL NUMBER OF THE GENERATOR WAS NOT REPORTED. THE USER FACILITY INDICATED THAT THE MONOPOLAR J HOOK HAD BEEN VISUALLY INSPECTED PRIOR TO USE AND THAT AFTER THE EVENT IT WAS NOTED THAT THE INSULATION ON THE DEVICE WAS DAMAGED. THE SERIAL NUMBER OF THE DEVICE WAS REPORTED TO BE EITHER (B)(4). THE USER FACILITY WAS UNSURE OF WHICH SERIAL NUMBER DEVICE WAS USED DURING THE CASE, AS THEY HAD SENT THE DEVICES TO A THIRD PARTY FOR REFURBISHING. THE FACILITY INFORMED (B)(4) THAT THEY WERE ROUTINELY SENDING THE DEVICES OUT TO A THIRD PARTY FOR REPROCESSING AND REFURBISHING. WHEN THE DEVICES WERE RECEIVED AT (B)(4) FOR RETURN TO THE MANUFACTURER ABMEDICA, IT WAS NOTED THAT THE DEVICES CONTAINED INSULATION THAT APPEARED TO BE VISUALLY DIFFERENT THAN THE ORIGINAL INSULATION. THE DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER ABMEDICA FOR EVALUATION.

    Description of Event or Problem · 1

    ON 2-10-2016, (B)(4), INITIAL IMPORTER AND DISTRIBUTOR FOR ABMEDICA (B)(4), BECAME AWARE OF AN ADVERSE EVENT THAT WAS PURPORTED TO HAVE OCCURRED AT A USER FACILITY, WHILE USING AN ABMEDICA MONOPOLAR J HOOK INSTRUMENT DURING A 40 MINUTE LAPAROSCOPIC CHOLECYSTECTOMY. THE EVENT WAS REPORTED TO (B)(4) BY THE USER FACILITY, (B)(6), WHO REPORTED THAT USE OF AN ABMEDICA MONOPOLAR J HOOK RESULTED IN A SKIN BURN TO THE PATIENT. THE DEGREE OF BURN AND EXACT LOCATION OF THE INJURY WAS NOT PROVIDED. HOWEVER, THE USER FACILITY INDICATED THAT "THE BURN WAS TREATED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED". THE ABMEDICA J HOOK WAS USED IN CONJUNCTION WITH A CONMED SABRE 600 GENERATOR AT SETTINGS OF CUT 35 AND COAG 50. THE SERIAL NUMBER OF THE GENERATOR WAS NOT REPORTED. THE USER FACILITY INDICATED THAT THE MONOPOLAR J HOOK HAD BEEN VISUALLY INSPECTED PRIOR TO USE AND THAT AFTER THE EVENT, IT WAS NOTED THAT THE INSULATION ON THE DEVICE WAS DAMAGED. THER SERIAL NUMBER OF THE DEVICE WAS REPORTED TO BE EITHER (B)(4). THE USER FACILITY WAS UNSURE OF WHICH SERIAL NUMBER WAS USED DURING THE CASE, AS THEY HAD SENT THE DEVICES TO A THIRD PARTY FOR REFURBISHING. THE FACILITY INFORMED (B)(4) THAT THEY WERE ROUTINELY SENDING THE DEVICES OUT TO A THIRD PARTY FOR REPROCESSING AND REFURBISHING. WHEN THE DEVICES WERE RECEIVED AT (B)(4) FOR RETURN TO THE MANUFACTURER ABMEDICA, IT WAS NOTED THAT THE DEVICES CONTAINED INSULATION THAT APPEARED TO BE VISUALLY DIFFERENT THAN THE ORIGINAL INSULATION. THE DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER ABMEDICA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141961 ABMEDICA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ABMEDICA SAS LIL-JH-35

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR