BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2913817 · Received December 5, 2012

    Report

    Report Number
    1717344-2012-01205
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 7, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR 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 TIP OF THE DEVICE BECAME LOCKED AND WOULD NOT OPEN ANYMORE. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL QUESTIONS REGARDING THE INCIDENT HAVE BEEN ASKED TO 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 23368OX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK