BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 4666647 · Received April 3, 2015

    Report

    Report Number
    2951238-2015-00154
    Event Type
    Malfunction
    Date Received
    April 3, 2015
    Date of Event
    March 4, 2015
    Report Date
    April 3, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO WORK WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO REGARDING THIS REPORT, AND IF NEW INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE UPDATED. THIS TYPE OF PROBE DAMAGE IS CONSISTENT WITH CONTINUOUS ACTIVATION OF THE DEVICE WITHOUT ANY TISSUE IN BETWEEN THE GRASPING SECTION AND PROBE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE PHYSICIAN INSTRUCTED THE NURSE TO CLEAN THE PROBE SECTION OF THE DEVICE. IT WAS FURTHER REPORTED THAT THE NURSE WAS QUITE ROUGH IN CLEANING THE PROBE. UPON THE NEXT ACTIVATION OF THE DEVICE, A PROBE DAMAGE ERROR MESSAGE OCCURRED. IT WAS THEN NOTICED THAT THE PROBE SECTION OF THE DEVICE BROKE OFF; HOWEVER, THE PROBE WAS STILL ATTACHED TO THE HANDLE AND DID NOT BREAK OFF INSIDE THE PT. IN ADDITION, THE PROBE WAS EXTRACTED BEFORE FALLING OFF COMPLETELY. THERE WAS NO PT INJURY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT BUT SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220791 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP GEI OLYMPUS MEDICAL SYSTEM CORP TB-0535FC

    Patients

    Seq Age Sex Outcome Treatment
    1