BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLS2 14C

    MDR report key: 2891650 · Received November 27, 2012

    Report

    Report Number
    1223422-2012-00005
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K62257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TLS2 14C AND A SMALL SEPARATE TIP INSULATION PIECE WERE RETURNED, DECONTAMINATED AND INVESTIGATED. A VISUAL INSPECTION OF THE TIP FOUND A SMALL TEAR IN THE INSULATION. A SMALL PIECE OF THE SILICONE BOOT WITH THE SILICONE ADHESIVE WAS SEPARATED FROM THE TIP. THE ROOT CAUSE IS CONSISTENT WITH INSERTION AND/OR EXTRACTION THROUGH THE CANNULA WITHOUT HAVING THE JAWS IN THE FULLY CLOSED POSITION PER THE INSTRUCTIONS FOR USE. THE TLS2 14CM REF 132-133D WITH LOT NUMBER 101017 WAS NOT RETURNED IN A TIMELY MANNER, THEREFORE, NO INVESTIGATION COULD BE CONDUCTED AND THIS COMPLAINT WAS CLOSED ON (B)(6) 2012. THE TLS2 14CM REF 132-133D WITH LOT NUMBER 101017 AND S/N (B)(4) WAS RETURNED, AN INVESTIGATION WAS CONDUCTED AND THIS COMPLAINT WAS DEEMED REPORTABLE.

    Description of Event or Problem · 1

    THE TIP'S INSULATION OF THE JAW WAS HANGING BY A THREAD DURING AN OPERATION. THE PATIENT IS OK. NO ADDITIONAL PATIENT INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLS2 14C THERMAL LIGATING SHEARS GEI MICROLINE SURGICAL INC. 132-133D 101017

    Patients

    Seq Age Sex Outcome Treatment
    1