BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 83903 · Received April 10, 1997

    Report

    Report Number
    1527736-1997-00549
    Event Type
    Malfunction
    Date Received
    April 10, 1997
    Date of Event
    March 5, 1997
    Report Date
    April 10, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A UNK. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971918. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, STAPLES IN NOSE, STAPLES IN THE TRACK, AND TRIGGER ENGAGED WITH PRECOCK, YES; NOSE SHROUD CRACKED/BROKEN; NO. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING WITH REGARD TO STAPLES FEEDING, FIRING AND FORMING. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS EXAMINED, WAS FOUND TO BE FUNCTIONAL, AND WAS CYCLED, FIRED, AND PROPERLY FORMED THE REMAINING 13 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT "WOULD ONLY FIRE TEN STAPLES" DURING SURGERY. 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 AN UNK PROCEDURE. IT WAS REPORTED THAT THE STAPLER WOULD ONLY FIRE TEN STAPLES. A NEW STAPLER WAS USED TO COMPLETE THE CASE WITHOUT COMPLICATIONS. THE SALES REP. BELIEVES THAT THE DEVICE JAMMED. 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 J4599X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other