BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 38951 · Received August 30, 1996

    Report

    Report Number
    1527736-1996-00034
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 21, 1996
    Manufacturer
    ETHICON ENDO-SURGERY INC
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EES# 964021/CIN. 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 DEVICE WAS INTRODUCED THROUGH THE TROCAR AND UPON ATTEMPTING TO FIRE, THE DEVICE BEGAN TO SPIT CLIPS ON EACH ATTEMPT. THE CLIPS WERE RETRIEVED LAPAROSCOPICALLY FROM THE ABDOMEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY INC NA HA4914

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other