BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRI PHANTOM

    MDR report key: 12580445 · Received October 5, 2021

    Report

    Report Number
    1020279-2021-07437
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 23, 2021
    Report Date
    November 15, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    IXG
    UDI-DI
    00885556198940
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION: H3, H6: THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE HAS A LARGE CRACK THAT SPANS ACROSS THE BODY OF THE GLASS CONTAINER, RENDERING THE DEVICE INOPERATIVE. IT IS UNDETERMINED IF ALL THE BROKEN COMPONENTS WERE RETURNED. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE PROBABLE CAUSES OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER: CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A MRI PHANTOM WAS DAMAGED DURING (B)(6) TRANSIT CAUSING TUBE TO BE BROKEN AND LIQUID TO LEAK OUT. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474766 MRI PHANTOM PHANTOM, ANTHROPOMORPHIC, RADIOGRAPHIC IXG SMITH & NEPHEW, INC. 14GM03859 00885556198940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown