BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 2222417 · Received July 14, 2011

    Report

    Report Number
    1717344-2011-00562
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 27, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BLUE PLASTIC INSULATION FELL OFF OF THE INSTRUMENT INTO THE PATIENT CAVITY. ALL OF THE MATERIAL WAS REMOVED FROM THE PATIENT SURGICAL SITE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE W/O INCIDENT. THERE WAS NO TISSUE DAMAGE AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 204966X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK