BEUDAMED
    FDA Adverse Event Other Summary report: N

    THUNDERBEAT

    MDR report key: 4925268 · Received July 14, 2015

    Report

    Report Number
    MW5044445
    Event Type
    Other
    Date Received
    July 14, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 14, 2015
    Manufacturer
    OLYMPUS
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC HYSTERECTOMY, DOCTOR WAS USING THUNDERBEAT HANDPIECE. IT REPEATEDLY ALARMED AND WOULD STOP WORKING. DEVICE WAS TAKEN APART AND RE-ASSEMBLED BY LYN CONTANT, CST. MULTIPLE PROBE CHECKS WERE DONE. DEVICE WAS UNPLUGGED AND RESTARTED. PROBLEMS CONTINUED. NEW (THUNDERBEAT) HANDPIECE WAS OBTAINED SO CASE COULD CONTINUE. ONE OF THE BLADES OF THE GRASPERS FELL OFF INSIDE THE PATIENT'S ABDOMEN. STRAY BLADE WAS IMMEDIATELY RETRIEVED, DEVICE EXAMINED, AND ALL PARTIES IN ROOM FELT ALL THE PIECES HAD BEEN FOUND AND REMOVED. NO HARM WAS CAUSED TO THE PATIENT. A NEW HANDPIECE WAS BROUGHT IN TO THE ROOM. NO OTHER INTERVENTION REQUIRED. THUNDERBEAT LOT # MK917272 EXPIRATION DATE IS 02/23/2015. THUNDERBEAT LOT # MK917248 EXPIRATION DATE IS 02/04/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457920 THUNDERBEAT FRONT ACTUATED GRIP GEI OLYMPUS MK917272
    457921 THUNDERBEAT FRONT ACTUATED GRIP GEI OLYMPUS MK917248

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other