BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXS DISPOSABLE ELECTRODE

    MDR report key: 3150392 · Received May 31, 2013

    Report

    Report Number
    1717344-2013-00401
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 21, 2013
    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). SNAP DAMAGE CAN BE CAUSED BY THE USER IMPROPERLY MISALIGNING THE SNAPS INTO THE MATING HOLES DURING ASSEMBLY. THIS DAMAGE CAN ALSO BE CAUSED BY MULTIPLE ASSEMBLY ATTEMPTS. THE INSTRUCTIONS FOR USE PROVIDE ADDITIONAL INFO ON THE PROPER METHOD OF ASSEMBLING THE ELECTRODES INTO THE REUSABLE INSTRUMENT. MFG PERFORMS A 100% VISUAL INSPECTION THAT INCLUDES CHECKING FOR DAMAGE TO THE SNAPS. IT IS UNLIKELY THE DEVICE LEFT THE COVIDIEN FACILITY IN THIS CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ELECTRODE DID NOT ACTIVATE. THE DEVICE WAS RETURNED FOR INVESTIGATION WITH A BROKEN AND MISSING SNAP PIN. THE CUSTOMER STATED THAT NO DEVICE COMPONENT FELL INTO THE PT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240444 AXS DISPOSABLE ELECTRODE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK