BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35MM FRONT-ACTUATED GRIP

    MDR report key: 3973289 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00280
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 15, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 16 MM FROM THE DISTAL END. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THERE WERE SCARS OF THE JAW. THE PROXIMAL SIDE OF THE PTFE PAD WAS WORN. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER ACTIVATED WHILE GRASPING A THICK AND HARD TISSUE, THE PROXIMAL SIDE OF THE PTFE PAD WAS WORN. AFTER THAT, THE PROBE AND JAW CAME INTO CONTACT EACH OTHER, AND PROBE CRACKED. AND PROBE BROKE, WHEN THE NURSE WIPED IT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HYSTERECTOMY, THE PROBE OF THE SUBJECT DEVICE WAS BROKEN. THIS EVENT WAS HAPPENED WHEN THE NURSE WIPED THE PROBE FOR CLEAN WITH GAUZE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331455 THUNDERBEAT 5MM 35MM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3301

    Patients

    Seq Age Sex Outcome Treatment
    1