BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUPLER II MAIN ASSEMBLY

    MDR report key: 14778107 · Received June 22, 2022

    Report

    Report Number
    2921578-2022-00008
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    May 23, 2022
    Report Date
    August 29, 2022
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430104534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATION, IT WAS FOUND OUT THAT THE COUPLER II DID NOT CONTRIBUTE TO THE INCIDENT AND INJURY WAS RELATED TO THE MAYFIELD SKULL CLAMP (CONCOMITANT PRODUCT) WHICH IS NOT MANUFACTURED BY MIZUHO OSI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAYFIELD SLIPPED DURING PATIENT TRANSFER RESULTING IN A CUT ON THE PATIENT'S HEAD AND THE COUPLER II DEVICE WAS SOMEHOW INVOLVED IN THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAYFIELD SLIPPED DURING PATIENT TRANSFER RESULTING IN A CUT ON THE PATIENT'S HEAD AND THE COUPLER II DEVICE WAS SOMEHOW INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308190 COUPLER II MAIN ASSEMBLY OPERATING TABLE, PRODUCT CODE: JEA JEA MIZUHO OSI 5873 00842430104534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other MAYFIELD SKULL CLAMP| MAYFIELD SKULL CLAMP