BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIZUHO OSI

    MDR report key: 5771884 · Received June 30, 2016

    Report

    Report Number
    MW5063230
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Report Date
    June 30, 2016
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MIZUHO OSI SURGERY TABLE TOPS MODEL 5943, PROBLEM: EPOXY GLUE DETACHING FROM ALUMINUM PLUG ATTACHMENT POINT. COULD CAUSE PT INJURY OR DEATH. FROM 2011 TIL 2016 HOSPITAL WOULD SEND TABLE TOPS BACK TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415212 MIZUHO OSI SPINAL SURGERY TABLE TOP JEA MIZUHO OSI 5943 SPINAL TOP

    Patients

    Seq Age Sex Outcome Treatment
    1