BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CONTROL I-BASE, DC

    MDR report key: 15901487 · Received December 2, 2022

    Report

    Report Number
    2921578-2022-00024
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 21, 2022
    Report Date
    February 24, 2023
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430106026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FROM THE INVESTIGATION, IT WAS DEEMED AS A USER ERROR AS THERE WAS MISUSE OF MIZUHO OSI TABLE ALONG WITH MAZOR X STEATH (NON-MIZUHO OSI PRODUCT) CONTRARY TO PUBLISHED INSTRUCTIONS BY MAZOR/MEDTRONIC THAT MENTIONED "THE SURGICAL TABLE MOVEMENT FEATURE MUST BE DISABLED DURING SURGERY WITH THE MAZOR X STEALTH EDITION SURGICAL SYSTEM". TABLE WAS ACTIVELY TILTED WITH THE MAZOR X ARM ATTACHED, WHICH CAUSED FAILURE OF THE TILT ACTUATOR DUE TO THE EXCESS MOVEMENT LOAD IMPARTED BY THE MAZOR X STEALTH ROBOT SYSTEM/ARM. IT IS ALSO BELIEVED THAT THERE WAS A MISUSE BY LACK OF REGULAR PREVENTATIVE MAINTENANCE OF A TABLE THAT IS 14+ YEARS OLD ALONG WITH OF DOCUMENTED YEARLY PREVENTATIVE MAINTENANCE. THE ADJUSTMENT OF THE HEAD AND FOOT END BRAKES WAS ALSO FOUND TO BE NON-COMPLIANT WITH THE SPECIFICATIONS MENTIONED IN THE OWNER'S MANUAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MIZUHO OSI TABLE WAS BEING USED WITH A MAPPING SYSTEM AND STAFF UNLOCKED THE TABLE TO ROLL IT BUT PATIENT ROLLED OFF THE TABLE IN DOING SO. NO REPORTED PATIENT INJURY. HOSPITAL STAFF SLOWLY LOWERED THE PATIENT TO THE GROUND. THE PATIENT WAS LIFTED BACK TO ANOTHER BED FOR IMAGING AND SAFETY PRECAUTIONS. CASE WAS CANCELLED AND RESCHEDULED FOR NEXT DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MIZUHO OSI TABLE WAS BEING USED WITH A MAPPING SYSTEM AND STAFF UNLOCKED THE TABLE TO ROLL IT BUT PATIENT ROLLED OFF THE TABLE IN DOING SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292341 ADVANCED CONTROL I-BASE, DC OPERATING TABLE JEA MIZUHO OSI 5803 00842430106026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown