BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 89866 · Received May 7, 1997

    Report

    Report Number
    1527736-1997-00859
    Event Type
    Malfunction
    Date Received
    May 7, 1997
    Date of Event
    March 24, 1997
    Report Date
    May 7, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR PROXIMATE LINEAR STAPLER WHILE PERFORMING A GASTRECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972158. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CARTRIDGE BATCH NUMBER J44X6V, CARTRIDGE POSITION LOADED, CASING POSITION BACK, HOOK SHROUD CONDITION GOOD, INSTRUMENT SERIAL NUMBER 1, LOCKOUT SLIDE POSITION UNLOCKED, NUMBER OF STAPLES RETURNED IN CARTR NONE, RETAINING PIN POSITION BACK, SAFETY POSITION UNLOCKED, TRIGGER POSITION OPEN/UNLOCKED. FUNCTIONAL TESTS & RESULTS: HOOK SHROUD CONDITION GOOD, INDICATOR FUNCTION PROPERLY YES, INDICATOR SETTING WHEN FIRING 2.5, KNOB COLLAR LOCKOUT SLOT CONDITION GOOD, LOCKOUT SLIDE TIP CONDITION GOOD, SAFETY DISENAGAE PROPERLY YES, STAPLE 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. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND IT FIRED AND FORMED ALL THE STAPLES AS DESIGNED. THEREFORE, IT COULD NOT BE ASCERTAINED AS TO WHY THE INSTRUMENT REPORTEDLY FIRED ON HALF OF THE STAPLE LINE. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOULSY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A GASTRECTOMY THE TL60 ONLY FIRED ON HALF OF THE STAPLE LINE. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other