BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 3161576 · Received May 7, 2013

    Report

    Report Number
    3006451981-2013-00180
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SEVERAL HOURS INTO A LAPAROSCOPIC OMENTECTOMY AND RESECTION OF INFERIOR BORDER OF PANCREAS, THE SURGEON HAD DIFFICULTY OPENING AND CLOSING THE JAWS. THE SURGEON HANDED THE DEVICE TO THE NURSE TO INSPECT AND IT WAS DETERMINED THAT THE JAW PIN WAS NO LONGER INSERTED IN THE DEVICE. THE SURGEON BELIEVES THAT THE JAW PIN MAY HAVE DETACHED WHEN HE PASSED THE DEVICE OFF AS HE DID NOT HAVE A PROBLEM OPENING AND CLOSING THE DEVICE WHILE IN THE ABDOMINAL CAVITY. THE SURGEON ALSO BELIEVES THAT IF THE PIN HAD FALLEN INTO THE PATIENT CAVITY, IT COULD HAVE BEEN EXTRICATED FROM THE CAVITY WHEN SUCTION OF THE SURGICAL CAVITY WAS PERFORMED AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197816 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S3AB020X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other