BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 46097 · Received September 18, 1996

    Report

    Report Number
    1527736-1996-00160
    Event Type
    Malfunction
    Date Received
    September 18, 1996
    Date of Event
    August 16, 1996
    Report Date
    September 18, 1996
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 CHOLESYSTECTOMY. THE CLIPS FROM THE DEVICE CAME OUT OF THE INSTRUMENT UNFORMED. THE FIRST CLIP REPORTEDLY WAS FINE, BUT THE SUBSEQUENT CLIPS WERE SPITTING OUT OF THE INSTRUMENT AND WOULD NOT FORM WHEN THE JAWS OF THE INSTRUMENT CLOSED. THE DEVICE WAS ONLY PLACED ACROSS THE CYSTIC DUCT. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 08/21/96 1400 TWO CLIPS FELL INTO THE PT AND WERE RETRIEVED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY NA J43A6C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other