BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 2243769 · Received July 29, 2011

    Report

    Report Number
    3006451981-2011-00095
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE DEVICE WOULD NO LONGER OPEN DURING THE PROCEDURE. THE DEVICE WAS REMOVED MANUALLY FROM TISSUE WITH NO LOSS OF OR DAMAGE TO TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE W/O INCIDENT. THERE WAS NO PATIENT INJURY. THE INCIDENT DEVICE WAS RETURNED AND A VISUAL INSPECTION REVEALED THAT THE SKI PIN ON THE HANDLE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1DB002X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK