BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82218 · Received February 27, 1997

    Report

    Report Number
    1527736-1997-00121
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 29, 1997
    Report Date
    February 11, 1997
    Manufacturer
    EES CINCINNATI .
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DID NOT PRODUCE STAPLES ON THE LEFT SIDE OF THE UTERUS" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THERE WERE PHOTOS RETURNED THAT SHOWED A BLEEDING VESSEL AND THE INSTRUMENT'S ANVIL BEING CLAMPED ON THE SURROUNDING TISSUE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS OCCURRED. 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 THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY DURING THE SECOND OR THIRD FIRING OF THE TSW35 ON THE LEFT SIDE OF THE UTERUS THE SURGEON NOTICED BLEEDING FROM THE CUT LINE. THE FIRING STROKE FELT NORMAL BUT NO STAPLES WERE OBSERVED TO BE PRESENT ALONG THE CUT LINE. THE BLEEDING WAS CONTROLLED USING AN ENDO CLIP APPLIER. THE SAME INSTRUMENT WAS FIRED 2 TO 3 MORE TIMES ON THE RIGHT SIDE WITH GOOD RESULTS. THE PT HAD INCREASED BLOOD LOSS, BUT NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/31/97 1420 MESSAGE AND 800 NUMBER LEFT FOR THE SURGEON TO CALL BACK. 2/3/97 1825 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG EES CINCINNATI . NA J4561P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other