BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1931530 · Received December 10, 2010

    Report

    Report Number
    1717344-2010-00922
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 15, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A MYOMECTOMY, THE DEVICE KNIFE WOULD NOT RETRACT AND WAS REPORTED AS PROTRUDING FROM THE JAWS WHEN IT WAS REMOVED FROM TISSUE. MANUAL SUTURING WAS USED TO COMPLETE THE PROCEDURE, EXTENDING THE PROCEDURE BY 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 190515L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK