BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82282 · Received February 20, 1997

    Report

    Report Number
    1527736-1997-00071
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 20, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D6: DEVICE RETURNED WITH NO LOT# IDENTIFICATION. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE RETURNED CARTRIDGE HAD DAMAGETO THE LOCKOUT TABS WHICH INDICATES THE FIRING CYCLE WAS STOPPED, RETURNED, THEN STARTED. 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 DEFORMATION COULD BE INDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. IF THE INSTRUMENTS'S FIRING CYCLE IS STOPPED, RETURNED, THEN RESTARTED, THE INSTRUMENT AND CARTRIDGE MAY BECOME DAMAGED. 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 ASSISTED VAGINAL HYSTERECTOMY THE TSW35 INADVERTENTLY LOCKED OUT ON THE SECOND FIRING. THE INSTRUMENT WAS RELOADED AND WORKED FINE. IT WAS USED FOR A TOTAL OF FIVE FIRINGS. THE RELOAD OUT WILL BE RETURNED. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW-UP 1/27/97 1540 OFFICE CLOSED FOR LUNCH. 1/27/97 1645 THE SURGEON STATED THE DEVICE WOULD NOT FIRE ON THE SECOND FIRING. HE STATED THE NURSE HAD NOT SQUEEZED THE DEVICE. THE STAPLES WERE COMING OUT UNFORMED FROM THE DEVICE. THE DEVICE WAS FIRED SEVERAL ADD'L TIMES WITHOUT DIFFICULTY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other