BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENEW CAUTERY PROBE HANDPIECE, 34CM

    MDR report key: 2989535 · Received February 28, 2013

    Report

    Report Number
    1223422-2013-00010
    Event Type
    Other
    Date Received
    February 28, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K981188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE REF 6924 PROBE WITH A SMALL BROKEN THREADED END PIECE WAS RETURNED, DECONTAMINATED AND INVESTIGATED. NO TIP WAS RETURNED, THEREFORE, NO INVESTIGATION COULD BE CONDUCTED ON THE TIP. AN INSPECTION OF THE RETURNED PROBE FOUND THAT THE BLUE TUBE END WAS BROKEN INSIDE OF THE INSULATION TUBE. THE KEVLAR TETHER STRAP ON THE CAUTERY CAP WAS BROKEN AND STUCK INSIDE OF THE HANDLE. THE DISTAL TIP OF THE INSULATION TUBE AND THE TUBE END HAD TOOL MARKS, WHICH ARE CONSISTENT WITH THE USE OF EXCESSIVE FORCE WHEN ASSEMBLING THE TIPS, HOWEVER A ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE TIP WAS NOT RETURNED. THE RENEW ELECTROCAUTERY PROBE HANDPIECE AND ELECTRODE TIPS INSTRUCTION FOR USE, PRECAUTIONS STATEMENT #3 STATES: DO NO USE MECHANICAL MEANS TO ASSEMBLE/DISASSEMBLE THE ELECTRODE TIP TO/FROM THE DEVICE. SERIOUS MALFUNCTION OF THE DEVICE MAY OCCUR.

    Description of Event or Problem · 1

    THE TIP BROKE OFF INSIDE THE PT AND WAS RETRIEVED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87150 RENEW CAUTERY PROBE HANDPIECE, 34CM CAUTERY PROBE, 34CM GEI MICROLINE SURGICAL INC. 6924 48955

    Patients

    Seq Age Sex Outcome Treatment
    1