BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABINET, X-RAY SYSTEM

    MDR report key: 17510437 · Received August 10, 2023

    Report

    Report Number
    MW5123012
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Report Date
    August 7, 2023
    Manufacturer
    BIOPTICS, INC.
    Product Code
    MWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE TARGET ADAPTER SCREW ONLY WENT HALFWAY INTO THE COREVISION ATTACHMENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DETAILS OF THE DEFECT HAVE BEEN CONFIRMED. ALTHOUGH IT WAS A PROBLEM ON COREVISION'S SIDE, THE SCREW DID NOT GO IN STRAIGHT WHEN THE ATTACHMENT WAS ATTACHED. THE DIRECTION OF THE HOLE ON THE RECEIVING SIDE WAS SLIGHTLY DIFFERENT SO IT ONLY FIT HALFWAY THROUGH WHEN THE ATTACHMENT WAS USED. NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS DUE TO THE COREVISION HANDLE AND NOT THE (B)(6) DEVICE DETAILED IN THE EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084158 CABINET, X-RAY SYSTEM COREVISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM MWP BIOPTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown