BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 39532 · Received August 30, 1996

    Report

    Report Number
    1527736-1996-00047
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 19, 1996
    Report Date
    August 30, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: ADDED EVALUATION CODES (CODE 400=YIELDED JAWS). RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE APPLIER WOULD NOT WORK PROPERLY. THE INSTRUMENT WAS SPITTING CLIPS THAT WERE UNFORMED. ANOTHER APPLIER WAS OPENED AND IT WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PT. 08/23/1996 1825 IT WAS REPORTED 3 CLIPS FELL INTO THE PT AND ALL WERE RETRIEVED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J42M98

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other