BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 81328 · Received April 2, 1997

    Report

    Report Number
    1527736-1997-00465
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 2, 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

    H6; CODE 100: INSTRUMENT RECEIVED EMPTY. FACILITY EXPERIENCED AN EVENT WITH YOUR 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 US WITH PRODUCT INQUIRY #971596. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, AND TRIGGER ENGAGED WITH PRECOCK; YES. NOSE SHROUD CRACKED/BROKEN, STAPLES IN NOSE, AND STAPLES IN THE TRACK; NO. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT; YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHY THE REPORTED INSTRUMENT "JAMMED" DURING SURGERY. THE INSTRUMENT WAS RECEIVED EMPTY, AND WAS CYCLED AND FOUND TO BE CONFORMING WITHIN DESIGN SPECIFICATIONS. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE INSTRUMENT BEING EMPTY. 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

    DURING A LAPAROSCOPIC HERNIA REPAIR-INGUINAL, IT WAS REPORTED BY THE AFFILIATE THAT THE FIRST FEW FIRINGS WORKED. THEN THE STAPLES WOULD NOT COME OUT WHEN THE HANDLE WAS DEPRESSED A FEW MINUTES. THEN IT WOULD WORK AGAIN BUT NO STAPLES APPEARED. DEVICE SEEMED TO BE JAMMED. A NEW DEVICE WAS INTRODUCED TO COMPLETED THE CASE. 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 J43L8G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other