BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIOS, TABLE BASE

    MDR report key: 19525178 · Received June 12, 2024

    Report

    Report Number
    2921578-2024-00005
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 22, 2024
    Report Date
    August 14, 2024
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430103957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION OBTAINED FROM THE INVESTIGATION, IT WAS FOUND OUT THAT THERE WERE NO PROBLEMS WITH THE DEVICE. THE PATIENT WAS POSITIONED PRONE ON THE SPINAL TOP FOR A RF ABLATION PROCEDURE WITH A SINGLE STRAP, ACROSS THE UPPER THIGHS, BELOW THE GLUTEAL FOLD. THE TABLE HAD BEEN TILTED FOR IMPROVED VISUALIZATION. WHEN THEY WENT TO LEVEL THE TABLE, THE PATIENT'S UPPER BODY CAME LOOSE AND SLID OFF. NO INJURIES TO THE PATIENT WERE IDENTIFIED. THE IFU OF THE DEVICE HAS INSTRUCTIONS PERTAINING TO THE APPLICATION OF BUTTOCK STRAP AND LEG SAFETY STRAP AND SUGGESTS AN ADDITIONAL SAFETY STRAP MAY BE APPLIED AROUND THE UPPER BODY AS APPLICABLE. THE PLACEMENT AND LOCATION OF THE STRAPS ARE STILL AT THE DISCRETION OF THE SURGEON AND VARY BY PROCEDURE. THE EXACT CAUSE OF THIS EVENT THUS REMAINS UNKNOWN AS MULTIPLE FACTORS SUCH AS CHALLENGING HABITUS, NON-OPTIMAL USAGE OF POSITIONING AND SAFETY STRAP AND/OR SURGEON'S DISCRETION COULD HAVE CONTRIBUTED TO THE OBSERVED PATIENT FALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WOMAN FELL FROM THE TRIOS TABLE WHEN IT WAS TILTED. SHE WASN'T STRAPPED AROUND THE TOP. THE TABLE WAS BARELY TILTED WHEN SHE FELL OFF AND HIT HER HEAD. A COUPLE DAYS LATER DOCTORS TOLD THE FSE (FIELD SERVICE ENGINEER) THAT IT WASN'T A JERK BUT SLIGHT MOVEMENT IN THE HEAD IN ASSEMBLY. FSE TOLD THEM MAXIMUM MOVEMENT IS TWO DEGREES (CLOCKWISE AND COUNTERCLOCKWISE) AND IT MEASURED AROUND 1 AT THE TIME OF INSPECTION SO IT IS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WOMAN FELL FROM THE TRIOS TABLE WHEN IT WAS TILTED. SHE WASN'T STRAPPED AROUND THE TOP. THE TABLE WAS BARELY TILTED WHEN SHE FELL OFF AND HIT HER HEAD. A COUPLE DAYS LATER DOCTORS TOLD THE FSE THAT IT WASN'T A JERK BUT SLIGHT MOVEMENT IN THE HEAD IN ASSEMBLY. FSE TOLD THEM MAXIMUM MOVEMENT IS TWO DEGREES (CLOCKWISE AND COUNTERCLOCKWISE) AND IT MEASURED AROUND 1 AT THE TIME OF INSPECTION SO IT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766303 TRIOS, TABLE BASE OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 7803 00842430103957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other