BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2860159 · Received November 30, 2012

    Report

    Report Number
    1717344-2012-01192
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 14, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION ON THE DEVICE DISLODGED. QUESTIONS WERE ASKED TO THE SITE REGARDING THE LOCATION OF THE CLEAR INSULATION BUT THEY HAD NO FURTHER DETAILS. THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 203854X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other