BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 82917 · Received March 7, 1997

    Report

    Report Number
    1527736-1997-00218
    Event Type
    Malfunction
    Date Received
    March 7, 1997
    Date of Event
    January 8, 1997
    Report Date
    March 7, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: DRY FIRED. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A MISC; COOPERS LIGAMENT. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971237. 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. STAPLES IN NOSE; YES (1 FORMED). FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT; NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT MAY HAVE BEEN DRY FIRED CAUSING THE STAPLE TO JAM BETWEEN THE HOLDER AND THE BACK OF THE ANVIL. THE INSTRUMENT WAS RECEIVED WITH A FORMED STAPLE IN THE NOSE AND WITH A YIELDED CARTRIDGE NOSE WELD. THE FORMED SAPLE WAS REMOVED FROM THE CARTRIDGE NOSE, BUT NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE YIELDED CARTRIDGE NOSE WELD, WHICH WOULD NOT ALLOW THE STAPLES TO PROPERLY FEED AND FORM. IT WAS CONCLUDED THAT THE NOSE WELD HAD YIELDED DUE TO THE INSTRUMENT BEING DRY FIRED AND THEN REFIRED WITH A FORMED STAPLE IN THE NOSE. THE INSTRUMENT IS NOT DESIGNED TO BE FIRED WHILE NOT IN TISSUE OR A GAUZE SIMULATION OF TISSUE. ONCE THE STAPLE IS FORMED, THERE IS NO MEDIA TO PULL THE STAPLE OUT OF THE TIP OF THE INSTRUMENT.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A COOPERS LIGAMENT PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED DURING FIRING CYCLE AND NOSTAPLE WOULD ADVANCE TO LOCK ON THE TISSUE. 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 EES-JUAREZ NA J4514F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other