BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 2851263 · Received November 27, 2012

    Report

    Report Number
    8010047-2012-00418
    Event Type
    Death
    Date Received
    November 27, 2012
    Date of Event
    October 16, 2012
    Report Date
    December 25, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS. THE FACILITY DIDN'T POINT THE PROBLEM OF THE SUBJECT DEVICE. OLYMPUS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION SUCH AS THE CAUSE OF BLEEDING AND DEATH. BUT NO MORE INFO COULD BE GET. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED ON (B)(6) 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT # 8010047-2013-00418 TO CORRECT DATE OF THIS REPORT.

    Description of Event or Problem · 1

    WHEN A PHYSICIAN USED THE SUBJECT DEVICE FOR A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, THE PHYSICIAN COULD RESECT ONE SIDE OF UTERUS WITHOUT BLEEDING. THE PHYSICIAN PROCEEDED TO THE OTHER SIDE OF UTERUS, THE PHYSICIAN ACTIVATED OUTPUT UNDER NOT SO CLEAR AREA OF VISION. THE PHYSICIAN TRIED TO STOP BLEEDING BUT WAS UNSURE WHERE THE BLEEDING WAS COMING FROM. THE PHYSICIAN DECIDED TO OPEN THE PT UP AND CONTINUE WITH AN OPEN HYSTERECTOMY WITHOUT THE SUBJECT DEVICE. THE PT DIED 2 DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC 22K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other