BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMK KIT W/SMKTC5

    MDR report key: 1051926 · Received May 23, 2008

    Report

    Report Number
    1717344-2008-00228
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. FURTHER INFORMATION AND THE SAMPLE HAVE BEEN REQUESTED. 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 REPORT STATED THAT THE STYLET BROKE DURING A PAIN ABLATION PROCEDURE. THE PIECE WAS RETRIEVED FROM THE PATIENT, AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMK KIT W/SMKTC5 ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 130687

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK