BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANON

    MDR report key: 10311582 · Received July 22, 2020

    Report

    Report Number
    2020563-2020-00005
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 3, 2020
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INCIDENT, IT APPEARS THAT THE TOUCH SENSOR ON THE BASE COVER OPERATED AS INTENDED, AND THE C-ARM EVACUATED FROM THE PINCHED LEG. AT THAT TIME, NO ERROR HAD OCCURRED. THE DEVICE APPEARS TO BE WORKING PROPERLY AND THE CUSTOMER THEMSELVES ACKNOWLEDGED RESPONSIBILITY FOR THIS MATTER. THE INJURED DOCTOR WENT TO THE HOSPITAL FOR TREATMENT, AND RETURNED TO WORK THE NEXT DAY. THIS ISSUE HAS BEEN ATTRIBUTED TO USER ERROR. ADDITIONALLY, THE OPERATION MANUAL WAS PROVIDED TO ALL CUSTOMERS AS A WARNING OF THIS INCIDENT IN (B)(6) 2013. FURTHERMORE, IN (B)(6) 2016, A WARNING POSTER AND LABEL WERE PROVIDED TO ALL CUSTOMER FOR THE NOTIFICATION AGAIN. THIS ISSUE HAS ONLY BEEN REPORTED AT (B)(6) HOSPITALS.

    Description of Event or Problem · 1

    DURING INTUBATION WORK IN C-ARM HEAD POSITION, CUSTOMER ALLEGED THAT THE DOCTOR BROKE HIS FIBULA AFTER LEG WAS PINCHED BETWEEN THE BASE COVER AND C-ARM OF THE SYSTEM WHEN THE OPERATOR MOVED THE C-ARM WITHOUT NOTICING THE DOCTOR'S LEG POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775630 CANON SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA CANON MEDICAL SYSTEMS CORPORATION INFX-8000V/J4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other