BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 4516624 · Received February 4, 2015

    Report

    Report Number
    8010047-2015-00086
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 14, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS DISCARDED BY THE USER FACILITY, THEREFORE OLYMPUS MEDICAL SYSTEMS CORP (OMSC) COULD NOT EVALUATE THE REFERENCED DEVICE. THE LOT.# OF THE DEVICE WAS UNKNOWN, HOWEVER THE MANUFACTURING HISTORY WITHIN THE 3 MONTHS OF PAST FROM A DELIVERY DAY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AND THIS DEVICE IS SUBJECT TO TOTAL INSPECTION TO ENSURE THAT THE DEVICE IS CAPABLE OF PROPERLY ACTIVATING OUTPUT BEFORE SHIPMENT BY OMSC. CONSIDERING THE REPORT FROM THE USER, OMSC CONCLUDED THAT REPORTED BURN AND BLEEDING OF THE NURSE OCCURRED SINCE SHE HAD THE GRASPING SECTION THAT WAS HOT AFTER ACTIVATING, WHEN SHE RECEIVED IT AFTER USE FROM A DOCTOR. AND THE DOCTOR AND THE FACILITY SAID THAT THE PHENOMENON WAS DUE TO THE BAD COOPERATION OF THE DOCTOR AND THE NURSE AND A MISTAKE OF THEM. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY CAUTIONS; THE GRASPING SECTION AND PROBE TIP BECOME HOT DUE TO EXTENDED ULTRASONIC OUTPUT. DO NOT LET IT COME IN CONTACT WITH TISSUES OTHER THAN THE TARGET TISSUE. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING LAPAROSCOPIC SIGMOID COLECTOMY. A SCRUB NURSE SUFFERED SECOND-DEGREE BURN, BECAUSE SHE HAD THE GRASPING SECTION OF THE DEVICE WHEN SHE RECEIVED IT FROM A DOCTOR JUST AFTER USE. AND SHE HAD A SCRAPE AROUND THE JOINT OF THUMB AND BLED. A DOCTOR DIAGNOSED HER BURN AND BLEEDING AS MILD-DEGREE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE AND OTHER NURSE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81060 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC

    Patients

    Seq Age Sex Outcome Treatment
    1