BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP

    MDR report key: 3002578 · Received February 14, 2013

    Report

    Report Number
    8010047-2013-00063
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO. THE USER FACILITY REPORTED THAT THE BROKEN TIP WAS RETRIEVED WITH A SPECIFIED TOOL. THE INTENDED PROCEDURE WAS COMPETED WITH A DIFFERENT PROBE WITH NO PT INJURY REPORTED. IT WAS UNK WHETHER THE BROKEN TIP HAD ANY SHARP EDGE OR NOT. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVAL. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFO THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE, THE TIP OF THE SUBJECT DEVICE WAS SAID TO HAVE BEEN BROKEN OFF DURING THE COAG CYCLE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65294 OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC 2JA043

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ESG-400 WITH UNK SERIAL NUMBER