BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH LINEAR CUTTERS

    MDR report key: 87341 · Received April 28, 1997

    Report

    Report Number
    1527736-1997-00791
    Event Type
    Malfunction
    Date Received
    April 28, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 28, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH LINEAR CUTTERS WHILE PERFORMING A SALPINGO-OOPHORECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO US WITH PRODUCT INQUIRY #972012. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: ANY OTHER NOTICEABLE DAMAGE, BATCH NUMBER, CARTRIDGE PAN IN PLACE/CONDITION, CONDITION OF DRIVERS, LOCKOUT TABS ON PAN CONDITION, AND POSITION/CONDITION OF WEDGE SLEDS; NA. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT, CONDITION OF CLAMPING MECHANISM, CONDITION OF FIRING MECHANISM, CONDITION OF KNIFE, AND CONDITION OF WEDGE BANDS; GOOD. IS HYPER LOCKOUT CONDITION PRESENT; NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE CARTRIDGE REPORTEDLY "FELL OUT OF THE INSTRUMETN" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. 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 THE PRODUCTS.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING AN OVARIAN CYSTECTOMY. IT WAS REPORTED THE INSTRUMENT WAS INTRODUCED INTO THE TROCAR. WHEN THE JAWS WERE OPENED, THE CARTRIDGE FELL OUT OF THE INSTRUMENT AND INTO THE PT'S ABDOMINAL CAVITY. THE CARTRIDGE AND INSTRUMENT WERE BOTH REMOVED AND A NEW TSB35 WAS OPENED AND USED WITHOUT DIFFICULTY. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH LINEAR CUTTERS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K46359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other