BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2023778 · Received February 15, 2011

    Report

    Report Number
    1717344-2011-00106
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE SAMPLE HAS BEEN REQUESTED, BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVALUATION. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HYSTERECTOMY, THE DEVICE JAWS GOT STUCK. THE JAWS WERE ABLE TO BE OPENED AGAIN AND THE DEVICE WAS CLEANED. APPROX 15 MINUTES LATER, THE KNIFE BLADE WOULD NO LONGER ADVANCE. AGAIN, THE DEVICE WAS CLEANED BUT THE SURGEON WAS STILL NOT ABLE TO OPERATE THE KNIFE. THE SITE REPORTED THAT THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES. BUT THEY WERE UNABLE TO SPECIFY BY HOW LONG THE PROCEDURE WAS EXTENDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, (VALLEYLAB) 190893

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK