BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 3800309 · Received May 2, 2014

    Report

    Report Number
    8010047-2014-00190
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OSMC) FOR EVALUATION. THERE IS NOTHING WRONG WITH THE DEVICE. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. FURTHERMORE, FROM PHYSICIAN'S COMMENT, THE POSSIBLE CAUSE OF THIS PHENOMENON IS THE INADEQUATE HANDLING BY THE PHYSICIAN. BASED UPON THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING USE THE SUBJECT DEVICE FOR A LAPAROSCOPIC TOTAL HYSTERECTOMY, THE PHYSICIAN HAD ACTIVATED THE OUTPUT WITH SQUEEZING THE CONTROL HANDLE INCOMPLETELY AND GRASPING A PART OF THE UTERINE ARTERY, AND THEN THE PATIENT HAD BECOME HEMORRHAGE. THE PHYSICIAN CHANGED TO THE OPEN SURGERY, AND COMPLETED THE PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THIS PHENOMENON WAS MISTAKEN SQUEEZING THE CONTROL HANDLE AND GRASPING OF THE UTERINE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263792 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC K3919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other