BEUDAMED
    FDA Adverse Event Other Summary report: N

    TLS3 35C, THERMAL LIGATING SHEARS

    MDR report key: 1884151 · Received October 14, 2010

    Report

    Report Number
    2954339-2010-00024
    Event Type
    Other
    Date Received
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    GEI
    PMA / PMN Number
    K062257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS FOR THE 2ND OF 3 DEVICES REPORTED (B)(6) 2010 BY THE SAME (B)(6) DISTRIBUTOR. THIS 2ND DEVICE REPORT IS ASSOCIATED WITH STARION INSTRUMENTS (B)(4). PRODUCT HAS BEEN REQUESTED BUT NOT RETURNED. THEREFORE NO INSPECTION COULD BE CONDUCTED. NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    COMPANY SALES REPRESENTATIVE WAS ADVISED THAT THE DISTRIBUTOR IN (B)(6) HAD THREE THERMAL LIGATING SHEAR FAILURES WHERE THE SILICONE BOOT CAME OFF. COMPLAINANT REPORTED. THIS HAD NEITHER AN EFFECT ON THE PROCEDURE ITSELF NOR ON THE PATIENT. PROCEDURE IDENTIFIED AS AN LAVH, LAVH HYSTEREKTOMIE. THIS REPORT IS ON THE 2ND OF 3 DEVICES IDENTIFIED, A TLS3 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLS3 35C, THERMAL LIGATING SHEARS GEI ELECTROSURGICAL, CUTTING & COAGULAT GEI STARION INSTRUMENTS 132-136D 001008

    Patients

    Seq Age Sex Outcome Treatment
    1