BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE HS XTD DISP ELEC/CORD

    MDR report key: 2935111 · Received January 25, 2013

    Report

    Report Number
    1717344-2013-00048
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 16, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 INFORMATION ON THE PROPER METHOD OF ASSEMBLING THE ELECTRODES INTO THE REUSABLE INSTRUMENT. MANUFACTURING 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. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 DID NOT ACTIVATE. THERE WAS NO ILL EFFECT TO THE PT. THE DEVICE WAS RETURNED FOR INVESTIGATION WITH ONE BROKEN AND MISSING SNAP PIN. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36221 LIGASURE HS XTD DISP ELEC/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 237903X

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other