BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 3961080 · Received May 26, 2014

    Report

    Report Number
    8010047-2014-00272
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. THIS WILL BE SUPPLEMENTED IF DEVICE EVALUATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING AN UNCERTAIN PROCEDURE, THE PTFE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED AFTER ABOUT 5 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310056 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC 42K

    Patients

    Seq Age Sex Outcome Treatment
    1