BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2854092 · Received October 17, 2012

    Report

    Report Number
    1717344-2012-01098
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HYSTERECTOMY, THE DEVICE DID NOT COMPLETELY SEAL THE TISSUE AND BLEEDING WAS NOTED BY THE SURGEON. THE AMOUNT OF BLEEDING WAS NOT PROVIDED BY THE SITE CONTACT. THE SITE CONTACT STATED THAT THE GENERATOR IN USE DID NOT PROVIDE END TONES THAT WOULD INDICATE A COMPLETED SEAL CYCLE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 183596

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR