BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMAL LIGATING SHEARS

    MDR report key: 3020625 · Received March 20, 2013

    Report

    Report Number
    1223422-2013-00008
    Event Type
    Other
    Date Received
    March 20, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K062257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE OPERATION, THE DEVICE WAS TAKEN OUT TO BE CLEANED. THE NURSE ATTEMPTED TO CLEAN THE TIP GENTLY BY WIPING VERTICALLY, THE SILICONE PEELED OFF COMPLETELY FROM ONE SIDE OF THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116239 THERMAL LIGATING SHEARS TLS3 35C GEI MICROLINE SURGICAL INC. 132-136D 201071

    Patients

    Seq Age Sex Outcome Treatment
    1