BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE TRIVERSE ES DEVICE COATED BLADE

    MDR report key: 2113006 · Received May 25, 2011

    Report

    Report Number
    1717344-2011-00414
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 16, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PREPARATION FOR SURGERY, THE DEVICE SELF ACTIVATED. IT WAS NOT USED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE TRIVERSE ES DEVICE COATED BLADE ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK