BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

    MDR report key: 1396641 · Received April 7, 2009

    Report

    Report Number
    3005075853-2009-02119
    Event Type
    Malfunction
    Date Received
    April 7, 2009
    Date of Event
    March 10, 2009
    Report Date
    March 13, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE INSTRUMENT WAS RETURNED FOR ANALYSIS. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE NOTED DURING TESTING. HOWEVER, DURING VISUAL INSPECTION THE DUCKBILL WAS NOTED TO HAVE EVIDENCE OF SHORT SHOT DURING THE MOLDING PROCESS. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE EVENT REPORTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, GAS LEAKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1