BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 3709135 · Received February 18, 2014

    Report

    Report Number
    3006451981-2014-00191
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    November 4, 2010
    Report Date
    November 17, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. THE INCIDENT DEVICE WAS PLUGGED INTO THE PLUG DOT PATTERN RECOGNITION FIXTURE AND FAILED. THE PLUG INTERMITTENTLY ILLUMINATED THE TEST FIXTURE INDICATING THAT THE PLUG DOTS WERE OFF-CENTERED. HOWEVER, WHEN PLUGGED INTO A FORCETRIAD GENERATOR, THE DEVICE WAS RECOGNIZED. THE DEVICE WAS TESTED ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS AND THE JAW FORCE READING WAS WITHIN SPECIFICATION. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. THE PLUG DOTS BEING OFF-CENTERED WOULD HAVE CAUSED A REGRASP ALARM TO SOUND, PROMPTING THE USER TO REGRASP THE TISSUE. A TOOLING CHANGE HAS BEEN MADE TO PRINT LARGER PLUG DOTS ON THE CABLE. THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OR VERIFIED BASED ON OUR TESTING OF THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OZZING UNDER 200CC WAS EXPERIENCED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. ANOTHER INSTRUMENT WAS USED TO SEAL THE VESSELS AND TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102407 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0EB035P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK