BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2902076 · Received November 28, 2012

    Report

    Report Number
    3006451981-2012-00218
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A NEPHRECTOMY, THE DEVICE STOPPED WORKING. THIS CAUSED THE PROCEDURE TO BE DELAYED BY MORE THAN 30 MINS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE W/O INCIDENT. THERE WAS NO BLEEDING, NO TISSUE DAMAGE AND NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK