BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 6001995 · Received October 5, 2016

    Report

    Report Number
    1717344-2016-00923
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    PMA / PMN Number
    K092879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. THE INCIDENT SAMPLE WAS REQUESTED BUT TO DATE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT: 11/23/2016. ONE USED LF1537 LIGASURE DEVICE WAS RECEIVED, AND EVALUATION OF THE SAMPLE DID NOT CONFIRM THAT THE JAWS WERE LOCKED CLOSED. VISUAL INSPECTION FOUND THE HANDLE WAS BROKEN BUT NOT LOCKED, AND THE HANDLE COULD NOT BE USED TO OPERATE THE LOOSE JAWS. DISASSEMBLY OF THE DEVICE CONFIRMED THIS TO BE DUE TO BROKEN LATCH TINES WITHIN THE HANDLE BODY. THIS BROKEN MECHANISM ALSO ALLOWED THE KNIFE BLADE TO BE DEPLOYED WHEN THE JAWS ARE OPEN. HOWEVER, THE INVESTIGATION COULD NOT RELIABLY DETERMINE THE CAUSE OF THE BROKEN LATCH TINES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT FOUND NO POTENTIALLY CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING INITIAL USE, THE JAWS OF THE DEVICE WOULD NOT OPEN AND THE HANDLE COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650543 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF1537 50160222X

    Patients

    Seq Age Sex Outcome Treatment
    1