BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 83917 · Received April 10, 1997

    Report

    Report Number
    1527736-1997-00545
    Event Type
    Malfunction
    Date Received
    April 10, 1997
    Date of Event
    March 11, 1997
    Report Date
    April 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: CARTRIDGE TOP FRONT BROKEN OFF AND THE LAST STAPLE TWISTED IN THE CARTRIDGE NOSE. 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 #971640. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, STAPLES IN NOSE, AND TRIGGER ENGAGED WITH PRECOCK, AB) YES; NOSE SHROUD CRACKED/BROKEN, A)YES B)NO; AND STAPLES IN THE TRACK, A)NO B)YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, A)NO B)YES. ANALYSIS CONCLUSION: A) NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT'S "DRIVERS NO LONGER PUSHED OUT THE STAPLES" DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH THE CARTRIDGE TOP FRONT BROKEN OFF AND IT WAS NOT RETURNED. THERE WERE EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. ONE STAPLE WAS REMAINING IN THE INSTRUMENT AND IT WAS TWISTED IN THE NOSE WITH A STAPLE LEG UNDER THE EJECTOR LEG. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO A BROKEN CARTRIDGE TOP FRONT AND NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE MAY HAVE OCCURRED. B) IT WAS CONCLUDED THAT EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY WAS CYCLED AND FIRED THE REMAINING 7 STAPLES INTERMITTENTLY. IT WAS CONCLUDED THAT THE EXCESSIVE DRIED FLUIDS CAUSED THE STAPLES TO FEED INTERMITTENTLY. AB) THE DRIVERS WERE EXAMINED AND WERE FOUND TO FUNCTION AS DESIGNED. AB) EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIORRAPHY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT AFTER FIRING ABOUT 7-8 STAPLES, IT WAS NOTED THAT THE DRIVERS NO LONGER PUSHED OUT THE STAPLES. THIS CAUSED THE STAPLES TO SLIP OVER EACH OTHER. A SECOND DEVICE WAS USED AND ONCE AGAIN AFTER THE 7-8 FIRING THE SAME DIFFICULTY OCCURRED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J41V56

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other