BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA MEDICAL IMAGING BOOM/ARM BRACKET

    MDR report key: 17711814 · Received September 7, 2023

    Report

    Report Number
    MW5145371
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 27, 2023
    Report Date
    September 1, 2023
    Manufacturer
    OMEGA MEDICAL IMAGING, LLC.
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ON THE TABLE AND SEDATED FOR COLONOSCOPY. THE OMEGA ENDOSCOPY EQUIPMENT USED FOR RADIOLOGY IMAGES DURING THE PROCEDURE UNEXPECTEDLY BECAME DISLODGED AT THE SITE WHERE THE BRACKET CONNECTS TO THE BOOM ARM CAUSING THE SCREEN/MONITOR EQUIPMENT TO FALL ONTO THE PATIENTS HAND/WRIST. FOUR SHORT SCREWS HOLDING THE BRACKET UP WERE COMPLETELY STRIPPED CAUSING IT TO FALL APART. X-RAY DONE ON PATIENT'S HAND THAT SHOWED SOFT TISSUE INJURY BUT LUCKILY NO FRACTURE. PATIENT HAD SWELLING AND BRUISING NOTED EXTERNALLY. OMEGA ENGINEERS FLEW IN FOR REPAIR AND REPLACED ALL FOUR SCREWS WITH LONGER SCREWS AND REPLACED THE ACTUATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118597 OMEGA MEDICAL IMAGING BOOM/ARM BRACKET INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB OMEGA MEDICAL IMAGING, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other