BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1251683 · Received December 1, 2008

    Report

    Report Number
    1717344-2008-00552
    Event Type
    Injury
    Date Received
    December 1, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 5, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE SITE HAS BEEN NOTIFIED THAT THE DEVICE KNIFE IS MISSING AND THEY HAVE BEEN ASKED IF THEY HAVE X-RAYS TO DETERMINE IF THE KNIFE HAS BEEN LEFT IN THE PATIENT. WE HAVE NOT RECEIVED ANY FURTHER INFORMATION FROM THE SITE AS TO THE STATUS OF THE KNIFE. WITHOUT ADDITIONAL INFORMATION, WE ARE REPORTING THIS AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    THE INITIAL REPORT STATED THAT THE DEVICE FAILED TO CUT DURING A LAPAROSCOPIC SIGMOID COLON RESECTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. UPON RECEIPT OF THE DEVICE, A VISUAL INSPECTION SHOWED THAT THE KNIFE BLADE WAS MISSING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 145602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other