BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 84603 · Received April 14, 1997

    Report

    Report Number
    1527736-1997-00587
    Event Type
    Malfunction
    Date Received
    April 14, 1997
    Date of Event
    March 14, 1997
    Report Date
    April 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: YIELDED CARTRIDGE NOSE WELD AND CARTRIDGE TUBE CRIMP. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A LAP HERNIA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971667. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, NOSE SHROUD CRACKED/BROKEN, STAPLES IN THE TRACK, AND TRIGGER ENGAGED WITH PRECOCK; YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT; NO.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REAPIR THE SURGEON WAS FIRING THE EMS INTO COOPERS LIGAMENT. THE HANDLE SEEMED TO BREAK AND THE DEVICE DID NOT RELEASE. THE SURGEON WAS USING A LOT OF PRESSURE TO FIRE THE DEVICE. A SECOND 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 MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J42932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other