BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2232571 · Received August 23, 2011

    Report

    Report Number
    1717344-2011-00725
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    August 1, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE INCIDENT DEVICE VERIFIED THAT THE DEVICE HAD A WIRE LOOP NEAR THE JAWS. THE MOVING JAW WIRE IS THE INTENDED DESIGN OF THIS DEVICE AND WILL NOT INTERFERE WITH THE FUNCTION OF THIS INSTRUMENT. THE DESIGN OF THIS DEVICE HAS BEEN CHANGED TO ADD A CLIP TO RETAIN THE WIRE AND ELIMINATE JAW WIRE SLACK THAT FORMS A LOOP AT THE JAWS. THIS DEVICE WAS MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A WIRE WAS FOUND PROTRUDING FROM THE TIP OF THE DEVICE AND THE SURGEON DID NOT WANT TO USE THE DEVICE AS A RESULT. THE NURSE WENT TO GET ANOTHER DEVICE BUT THE SURGEON DECIDED TO CONVERT TO AN OPEN PROCEDURE BEFORE THE NURSE WAS ABLE TO RETURN WITH THE REPLACEMENT LAPAROSCOPIC PRODUCT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 175789

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other