BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 87356 · Received April 24, 1997

    Report

    Report Number
    1527736-1997-00778
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Report Date
    April 24, 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

    FACILITY EXPERIENCED AN EVENT WITH YOUR PROXIMATE LINEAR CUTTER WHILE PERFORMING AN UNKNOWN. THE PRODUCT COMPLAINT ANALYSIS TEAM COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972462. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CAM POSITION: ENGAGED/DISENGAGED DISENGAGED, CARTRIDGE BATCH NUMBER J44T3C, CARTRIDGE POSITION: LOADED, DRIVERS PRESENT IN CARTRIDGE PRESENT/UP - PROX., FIRING KNOB POSITION: BACK/PARTIAL BACK, GAPSPACE PIN CONDITION: GOOD, HOOK LATCH POSITION: OPEN/CLOSED CLOSED, INSTRUMENT HALVES: JOINED/SEPARATE JOINED, KNIFE CONDITION: GOOD, STAPLES PRESENT? FORMED/UNFORMED 4 FORMED STAPLES RE, SWING TAB POSITION: LOCKED/UNLOCKE LOCKED. FUNCTIONAL TESTS & RESULTS: INSTRUMENT SAFETY LOCKOUT PROPERLY YES, STAPLES HEIGHTS CONFORMING N/A, STAPLES FIRE PROPERLY YES, STAPLES FORM PROPERLY YES. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. UPON RECEIPT OF THE INSTRUMENT, IT WAS NOTED THAT ALL THE DRIVERS WERE IN THE UP POSITION. ADDITIONALLY, IT WAS NOTED THAT THE PROXIMAL FIRST SET OF DRIVERS WERE UP FARTHER THAN THE PHTER DRIVERS. DUE TO THE CONDITION OF THE DRIVERS, IT APPEARD POSSIBLE THAT AN ATTEMPT MAY HAVE BEEN MADE TO FIRE A SPENT CARTRIDGE. IT SHOULD BE NOTED THAT THE CARTRIDGE IS DESIGNED TO LOCK-OUT WHEN ANY OF THE STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE WOULD NOT FIRE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J4523Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other