BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER

    MDR report key: 86086 · Received April 17, 1997

    Report

    Report Number
    1527736-1997-00672
    Event Type
    Malfunction
    Date Received
    April 17, 1997
    Report Date
    April 17, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEAR DR. UNKNOWN IT WAS REPORTED BY HARRY FOERSTER (7008WW) THAT YOUR EXPERIENCED AN EVENT WITH YOUR PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER WHILE PERFORMING A UNK PROCEDURE. PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972297. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CONDTION OF ANVIL GOOD, CONDITION OF ANVIL SHROUD GOOD, CONDITION OF CARTRIDGE GOOD, CONDITION OF DRIVER GOOD, CONDITION OF EARMUFF GOOD, CONDITION OF HEAD GOOD, FIRING LEVER POSITION OPEN, ROTATION GOOD, STAPLES PRESENT YES, TRIGGER POSITION OPEN. FUNCTIONAL TESTS & RESULTS: CLOSURE FORCE CLOUSE LINK BROKEN, INSTRUMENT CYLCED NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY DAMAGE TO THE INTERNAL COMNPONENTS. THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A BROKEN CLOSURE LINK. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF INSTRUMENT IS ATTEMPTED TO BE CLOSED OVER TISSUE THAT IS TOO THICK, THE CLOSURE LINK CAN BECOME DAMAGED, MAKING THE INSTRUMENT NON-FUNCTIONAL. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE DOES NOT FIRE/MISFIRE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER LINEAR STAPLES GAG ETHICON ENDO-SURGERY, INC. NA H4098T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other