BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROHYDRAULIC LITHOTRIPSY PROBE

    MDR report key: 3161794 · Received June 6, 2013

    Report

    Report Number
    2183680-2013-00033
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    FFK
    PMA / PMN Number
    K980492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP WAS BURNING UP DURING A SURGICAL PROCEDURE. THE SURGEON TRIED THE THREE THAT CAME IN A PACK WITH THE SAME LOT NUMBERS AND THEY ALL FAILED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT LOT NUMBER OF THE SAME PRODUCT WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251338 ELECTROHYDRAULIC LITHOTRIPSY PROBE ELECTROHYDRAULIC LITHOTRIPSY PROBE FFK GYRUS MEDICAL INC E-1F MK532028

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK