BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUDERBEAT 5NN, 35CM, FRONT-ACTUATED GRIP

    MDR report key: 3489858 · Received September 25, 2013

    Report

    Report Number
    8010047-2013-00490
    Event Type
    Malfunction
    Date Received
    September 25, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 29, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 15 MM FROM THE DISTAL END. AND THERE WAS A SCRATCH AT THE UPSIDE OF THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF THE EVALUATION, WE HAVE CONCLUDED THAT THE PROBE PRESUMABLY WAS SCRATCHED BECAUSE OF THE PHYSICIAN ACTIVATED ULTRASOUND OUTPUT WHILE THE PROBE WAS IN CONTACT WITH METAL SUCH AS A CLIP AND FORCEPS OR THE PHYSICIAN SCRAPE AND PROBE WITH A SHARP OBJECT SUCH AS A SCALPEL. IN ADDITION, SINCE THE PHYSICIAN CONTINUED TO USE THE SCRATCHED DEVICE, THE CRACK OF THE PROBED OCCURRED AND ERROR DISPLAYED. CONSEQUENTLY, DURING THE EXAMINATION OUTSIDE THE PATIENT, THE PROBE TIP BROKE. THE INSTRUCTION MANUAL OF THE THUNDERBEAT SCISSORS MENTIONS WARNING AND CAUTION OF POSSIBLE MISHANDLING MENTIONED ABOVE. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER MISHANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHEN AN ERROR DISPLAYED DURING A PROCEDURE, THE PROBE TIP WAS BROKEN BY CLEANING AND THIS WAS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485516 THUDERBEAT 5NN, 35CM, FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE. GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3426

    Patients

    Seq Age Sex Outcome Treatment
    1