BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM PISTOL GRIP

    MDR report key: 3815224 · Received April 24, 2014

    Report

    Report Number
    8010047-2014-00195
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 27, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OLYMPUS (B)(6) RECEIVED SOME DEVICES ERROR OCCURRED FROM HOSPITAL. IT WAS FOUND THAT THE PTFE PAD OF ONE DEVICE WAS PARTIALLY WORN AWAY. THERE WAS NO PATIENT HARM REPORTED. THE OCCURRENCE DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249482 THUNDERBEAT 5MM 35CM PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC K3227

    Patients

    Seq Age Sex Outcome Treatment
    1