BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 3070964 · Received April 2, 2013

    Report

    Report Number
    8010047-2013-00091
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 13, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT, BUT WITH NO RESULT. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE SUBJECT DEVICE IS RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE THE TEFLON PAD CAME OFF OF THE JAWS, AND THE JAW OF THE SUBJECT DEVICE BROKE OFF AT THE HINGE. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED USING A THIRD THUNDERBEAT HANDPIECE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133480 OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEM CORP TB-0535PC 27K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK