BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2893942 · Received December 18, 2012

    Report

    Report Number
    1717344-2012-01249
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAW WOULD NO LONGER OPEN DURING THE CASE. THE DEVICE WAS NOT ON TISSUE AT THE TIME. THERE WAS NO INJURY TO THE PT. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE CLEAR INSULATION WAS NOT ATTACHED AND MISSING. THE CUSTOMER COULD NOT ACCOUNT FOR THE CLEAR INSULATION BUT DOES NOT BELIEVE THAT IT CAME OFF OF THE DEVICE BEFORE IT WAS PACKAGED TO BE SENT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 239171X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other