BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4120838 · Received July 28, 2014

    Report

    Report Number
    1717344-2014-00642
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 22, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 DEVICE JAWS COULD NOT BE RE-OPENED DURING A PROCEDURE. THE SITE CONTACT DID NOT KNOW IF THE JAWS WERE APPLIED TO TISSUE WHEN THIS OCCURRED. THERE WAS NO PATIENT INJURY REPORTED. THE SITE CONTACT WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE DEVICE OR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439885 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 41420245X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK