BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 118569 · Received September 9, 1997

    Report

    Report Number
    1527736-1997-02255
    Event Type
    Malfunction
    Date Received
    September 9, 1997
    Report Date
    August 12, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: BATCH NUMBER AB K01040 C K01, CARTRIDGE PAN IN PLACE/CONDITION ABC YES/GOOD, CONDITION OF DRIVERS ABC GOOD, LOCKOUT TABS ON PAN CONDITION ABC GOOD, POSITION/CONDITION OF WEDGE SLEDS AB FULLY FIRED C UNF. FUNCTIONAL TESTS & RESULTS: CONDITION OF CLAMP FIRST LOCKOUT GOOD, CONDITION OF CLAMPING MECHANISM GOOD, CONDITION OF FIRING MECHANISM GOOD, CONDITION OF KNIFE GOOD, CONDITION OF WEDGE BANDS GOOD, IS HYPER LOCKOUT CONDITION PRESENT NO, RESULT OF ATTEMPTED FIRING GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY PRODUCED "STAPLE LINE BLEEDING" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. 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 PRODUCTS.

    Description of Event or Problem · 1

    THE ATW35 WAS USED DURING A LAPAROSCOPIC SIGMOID RESECTION. IT WAS REPORTED THE CASE COVERTED TO OPEN DUE TO DIFFICULTY WITH ANATOMY. THE ATW35 WAS ALREADY OPENED AND THE SURGEON DECIDED TO STILL USE IT AFTER HE CONVERTED THE PROCEDURE. THE DEVICE WAS FIRED THREE TIMES TO DIVIDE THE MESENTERY. ON AT LEAST TWO FIRINGS THERE WAS BLEEDING IN THE MIDDLE OF THE STAPLE LINES WHICH REQUIRED ADD'L OVERSEWING WITH SUTURE TO ACHIEVE HEOMOSTASIS. THE REP IS RETURNING THE RELOADS TR35W WITH THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT. 8/18/1997 IT REPORTED THE STAPLE LINE LOOKED NORMAL, BUT WAS BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K4T806

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other