BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1881630 · Received October 20, 2010

    Report

    Report Number
    1717344-2010-00711
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COVIDIEN REFERENCE # (B)(4). DATE OF INITIAL REPORT: 10/20/2010. THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COVIDIEN REFERENCE # :(B)(4). DATE OF INITIAL REPORT :10/20/2010. DATE OF FOLLOW-UP REPORT: 01/26/2011. THE RETURNED DEVICE COULD NOT BE TESTED DUE TO A CRACKED BODY NEAR THE SWITCH. IT CANNOT BE DETERMINED HOW OR WHEN THIS DAMAGE OCCURRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD, BUT THE DEVICE WAS NOT SEALING PROPERLY AND THE SEALS DID NOT HOLD. THE CUSTOMER SAID IT APPEARED THAT THE DEVICE WAS UNDERPOWERED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351540 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown