BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE HS MAX DISP ELECT/CORD

    MDR report key: 2872562 · Received December 6, 2012

    Report

    Report Number
    1717344-2012-01217
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 28, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    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 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 THERE WHEN THE DEVICE WAS CONNECTED, THE GENERATOR GENERATED AN ALARM. THE DEVICE WAS RETURNED TO THE MFR WITH TWO BROKEN AND MISSING SNAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE HS MAX DISP ELECT/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 216767X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK