BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGASURE ADVANCE PISTOL GRIP

    MDR report key: 2980960 · Received February 4, 2013

    Report

    Report Number
    1717344-2013-00060
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 9, 2013
    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 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 DEVICE WAS LOCKING. THERE WAS NO INJURY. NO FURTHER INFORMATION IS AVAILABLE FROM THE SITE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45882 IGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 231595X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK