BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIOS SURGICAL TABLE

    MDR report key: 14161950 · Received April 20, 2022

    Report

    Report Number
    2921578-2022-00006
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    April 8, 2022
    Report Date
    March 6, 2023
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430103957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT SECUREMENT TO THE TABLE WAS INSUFFICIENT FOR THE DESIRED DEGREE OF TILT.

    Additional Manufacturer Narrative · 0

    A FALL WAS INITIALLY REPORTED IN RELATION TO MIZUHO OSI TABLE. AFTER COMMUNICATING WITH USER FACILITY, THEY INDICATED THAT MIZUHO OSI TABLE WAS NOT INVOLVED IN THE INCIDENT. THUS, THE INITIAL REPORT WAS ERRONEOUS.

    Description of Event or Problem · 0

    AN INCIDENT OF PATIENT FALLING FROM THE TABLE WAS REPORTED. AN OPERATIONAL CHECK OF THE TABLE WAS PERFORMED WHICH CONCLUDED HAVING NO PROBLEM WITH THE TABLE. IT WAS REPORTED BY OR LEAD COORDINATOR THAT ONE OF THE NURSES HAD PUT SOME FOOT BOARDS ON THE TABLE WHICH CAUSED THE INCIDENT OF PATIENT FALL. THIS WAS DEEMED AS OPERATOR'S ERROR WITH NO REPORTS OF PATIENT INJURY.

    Description of Event or Problem · 0

    PROCEDURE WAS T5 TO T10 LAMINECTOMY WITH MICROSCOPIC DISSECTION AND TUMOR RESECTION. PATIENT WAS PRONE, LOWER BODY SECURED TO TABLE. THE TABLE WAS AIRPLANED TO IMPROVE SURGICAL ACCESS. PATIENT SLID OFF THE TABLE ONTO THE FLOOR.

    Description of Event or Problem · 0

    AN INCIDENT OF PATIENT FALLING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659112 TRIOS SURGICAL TABLE OPERATING TABLE JEA MIZUHO OSI 7803 00842430103957

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other