BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE HS XTD DISP ELEC/CORD

    MDR report key: 3823694 · Received May 1, 2014

    Report

    Report Number
    1717344-2014-00383
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SITE ORIGINALLY REPORTED THAT THE DEVICE STOPPED WORKING AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE. UPON RECEIPT OF THE DEVICE FOR INVESTIGATION, IT WAS NOTED THAT THERE WAS 1 BROKEN/MISSING SNAP PIN. THE SITE WAS CONTACTED REGARDING THE BROKEN/MISSING SNAP PIN. THE SITE CONFIRMED THAT THE PIN BROKE UPON CONNECTING THE HANDPIECE. THE BROKEN PIN DID NOT FALL INTO THE PATIENT'S CAVITY BUT WENT MISSING AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261037 LIGASURE HS XTD DISP ELEC/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 33160032X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK