BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE HS MAX DISP ELECT/CORD

    MDR report key: 6094594 · Received November 10, 2016

    Report

    Report Number
    1717344-2016-01046
    Event Type
    Injury
    Date Received
    November 10, 2016
    Report Date
    October 5, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    PMA / PMN Number
    K043273
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LS3092 LIGASURE DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED ISSUE WAS NOT CONFIRMED. TESTING OF THE DEVICE FOUND IT WAS RECOGNIZED BY THE GENERATOR AND THERE WERE NO ISSUES WITH THE CORD DOT-RECOGNITION FIXTURE. SEALING WAS PERFORMED MULTIPLE TIMES ON SIMULATED TISSUE, AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY WITH END TONES. HOWEVER, AN ALTERNATE AND NON-CONTRIBUTING ISSUE WAS IDENTIFIED. VISUAL INSPECTION FOUND ONE OF THE SNAPS ON THE JAW WAS BROKEN AND MISSING. REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT FOUND NO POTENTIALLY CONTRIBUTING FACTORS. A 100% VISUAL INSPECTION OF THE SNAP PINS IS PERFORMED DURING PRODUCTION, AND IT IS UNLIKELY THE PRODUCT WAS DAMAGED WHEN IT LEFT THE MANUFACTURING FACILITY. SNAP DAMAGE CAN BE CAUSED BY MISALIGNING THE SNAPS DURING ASSEMBLY BY THE USER OR BY MULTIPLE ASSEMBLY ATTEMPTS. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE DAMAGE TO BE USER ERROR. THE INSTRUCTIONS FOR USE INCLUDED WITH THIS PRODUCT LISTS MEASURES FOR PROPER ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT WORK. EXAMINATION OF THE RECEIVED SAMPLE ON (B)(6) 2016 FOUND A SNAP PIN FROM THE ELECTRODE IS MISSING AND WAS NOT RETURNED. IT IS UNKNOWN IF THE MISSING PIECE FELL WITHIN THE PATIENT. MULTIPLE ATTEMPTS FOR FURTHER INFORMATION ON THE LOCATION OF THE DETACHED PIECE HAVE BEEN MADE, AND NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742976 LIGASURE HS MAX DISP ELECT/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LS3092 60060131X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other