BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 3031295 · Received March 5, 2013

    Report

    Report Number
    1717344-2013-00161
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 11, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE INCIDENT DEVICE REVEALED THAT THE BLUE NYLON INSULATION WAS DAMAGED DUE TO A THERMAL INDUCED NYLON DISTORTION. NO INSULATION WAS MISSING. A FAILURE INVESTIGATION WAS CONDUCTED FOR THIS ISSUE. REPEATED DEVICE ACTIVATION AND HIGH DUTY CYCLE CAN LEAD TO HIGH TEMPERATURES THAT CAUSE DELAMINATION OF THE NYLON COATING. WE HAVE BEEN ABLE TO DUPLICATE THIS IN OUR INVESTIGATION TESTING. THE PRODUCT INSTRUCTIONS FOR USE (IFU) WARN AGAINST USING THE DEVICE AS A BIPOLAR SCISSOR WHICH CAN MIMIC THE REPEATED ACTIVATION/HIGH DUTY CYCLE SCENARIO. THE IFU ALSO INDICATES TO KEEP THE JAWS CLEAN AND NOT TO ACTIVATE THE JAWS IF THEY ARE SUBMERGED IN FLUIDS. THESE INCIDENTS DO NOT TYPICALLY PRESENT ANY HARM TO THE PT. ATTEMPTS TO PRODUCE A COATING THAT CAN WITHSTAND CUSTOMER MISUSE HAVE NOT BEEN SIGNIFICANTLY SUCCESSFUL IN ELIMINATING THE FAILURE MODE COMPLETELY. COMPLAINTS CONTINUE TO OCCUR AT A LOW RATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THE DEVICE MELTED WHILE IN USE. NO FURTHER INFO WAS MADE AVAILABLE BY THE SITE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94760 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 226679X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK