BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82125 · Received February 25, 1997

    Report

    Report Number
    1527736-1997-00075
    Event Type
    Malfunction
    Date Received
    February 25, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 24, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLSUION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "LOCKED OUT" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE RETURNED CARTRIDGEHAD BENT LOCKOUT TABS ON THE PAN WHICH INDICATES THAT THE FIRING CYLCE WAS INTERRUPED, RELEASED, AND RESTARTED. IF THE FIRING CYCLE IS INTERRUPTED, RELEASED, AND THEN RESTARTED, THE INSTRUMENT AND CARTRIDGE MAY BECOME DAMAGED. 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 A LAPAROSCOPIC OVARIAN CYSTECTOMY THE SURGEON FIRED THE TSW35 TWICE. ON THE THIRD FIRING OF THE DEVICE IT LOCKED OUT. THE TR35W CARTRIDGE WAS REPLACED AND THE DEVICE LOCKED OUT AGAIN. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. ONE TR35W RELOAD IS BEING RETURNED FOR ANALYSIS, LOT # J45L2N, BATCH # J00N6T. CLINICAL FOLLOW UP: 1/31/97 1049 MESSAGE AND 800# LEFT FOR MD CALL BACK. 2/3/97 1735 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG EES-CINCINNATI NA J45N4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other