BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 92434 · Received May 20, 1997

    Report

    Report Number
    1527736-1997-00972
    Event Type
    Malfunction
    Date Received
    May 20, 1997
    Date of Event
    April 15, 1997
    Report Date
    May 20, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: HEAD HOUSING BROKEN OFF AND NOT RETURNED. HEAD HOUSING WELD FOUND TO BE SUFFICIENT. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING LAP HERNIA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972504. THE RESULTSOF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES A)NO BCD)YES, NOSE SHROUD CRACKED/BROKEN ABCD)NO, STAPLES IN NOSE ABD)NO B)1 FORMED, STAPLES IN TRACK ABCD)YES, TRIGGER ENGAGED WITH PRECOCK ABCD)YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT A)NO BCD)YES. ANALYSIS CONCLUSION: ABCD)IT WAS CONCLUDED THAT THE;A)LEFT SIDE HEAD HOUSING HAD BROKEN OFF DURING SURGERY AND WAS NOT RETURNED, MAKING THE INST. NON FUNCTIONAL. NO CONCLUSION COULD BE REACHED HOW THIS DAMAGE MAY HAVE OCCURRED. B)INCIDENT DURING SURGERY MAY HAVE BEEN DUE TO A DRY FIRE WHERE THE STAPLE WAS NOT SECURELY ATTACHED TO THE TISSUE, CAUSING THE STAPLE TO RETRACT, AND JAM IN THE NOSE. THE FORMED STAPLE WAS REMOVED FROM THE NOSE AND THE INST. THEN FIRED THE REMAINING 14 STAPLES WITHOUT INCIDENT. C)INCIDENT DURING SURGERY MAY HAVE BEEN DUE TO EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE. THE INST. FIRED AND PROPERLY FORMED THE REMAINING 8 STAPLES INTERMITTENTLY, DUETO THE EXCESSIVE DRIED FLUIDS. D)INST. WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INST. WAS RECEIVED WITH A DAMAGED EJECTOR LEG, BUT FIRED AND PROPERLY FORMED THE REMAINING 8 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED HOW THE EJECTOR LEG HAD BECOME DAMAGED. ACD)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. C)THE INSTRUMENT IS NOT DESIGNED TO BE FIRED WHILE NOT IN TISSUE OR GAUZE SIMULATION OF TISSUE. ONCE THE STAPLE IS FORMED, THERE IS NO MEDIA TO PULL THE STAPLE OUT OF THE TIP OF THE INSTRUMENT. A)THE INSTRUMENT'S ROTATING HEAD HOUSING WELD MAY BECOME COMPROMISED IF EXCESSIVE PRESSURE IS APPLIED AT THE DISTAL END OF THE INSTRUMENT DURING FIRING.

    Description of Event or Problem · 1

    THE DEVICES WERE USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WOULD NOT ADVANCE AND THE DEVICES WERE JAMMED (NO MORE DETAILS). THERE WAS NO PATIENT 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other