BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82118 · Received February 25, 1997

    Report

    Report Number
    1527736-1997-00076
    Event Type
    Malfunction
    Date Received
    February 25, 1997
    Date of Event
    January 27, 1997
    Report Date
    February 25, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TIGHT SALPINGO-OOPHRECTOMY THE TSW35 FIRED BUT AT THE PROXIMAL END OF THE STAPLE LINE THERE WAS BLEEDING. THIS HAPPENED WITH THE FIRST TWO FIRINGS. THERE WAS NO CONSEQUENCE TO THE PT. 1/30/97 THE BLEEDING WAS CONTROLLED BY USING THE BIOPOLAR FORCEPS. NO BLOOD TRANSFUSION WAS REQUIRED. THE CASE WAS COMPLETED WITH THE TSW35. CLINICAL FOLLOW UP: 1/31/97 1139 MESSAGE AND 800# FOR MD CALL BACK. 2/3/97 1745 NNCL SENT.

    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