BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHSCO,4/140_30_QIK/STRKR HUB

    MDR report key: 8416751 · Received March 13, 2019

    Report

    Report Number
    1221934-2019-56608
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    January 29, 2019
    Report Date
    January 29, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705026234
    PMA / PMN Number
    K971996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (UDI): (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT SERVICE CENTER AND EVALUATED. THE FOGGY IMAGE CONFIRMS THE REPORTED FAILURE, INTERNAL SCOPE WAS CLEANED TO ADDRESS THE ISSUE. THE DISTAL TIP, OBJECTIVE, OPTICS WERE DAMAGED AND THEY WERE REPLACED. DEVICE MISHANDLING IS A POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE. OTHER THAN THAT WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (PRODUCT CODE: 242043, SERIAL NUMBER: (B)(4)), AND NO NON-CONFORMANCES WERE IDENTIFIED. THE TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REPRESENTATIVE VIA PHONE, THE PICTURE LOOKS LIKE IT IS IN BLACK AND WHITE WHEN VIEWING THROUGH THE SCOPE. THEY WERE ABLE TO COMPLETE THE CASE BY USING ANOTHER LIKE DEVICES WITH NO PATIENT HARM OR DELAY IN THE CASE. NO FURTHER INFORMATION AVAILABLE TO THE SALES REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211333 ARTHSCO,4/140_30_QIK/STRKR HUB RIGID ENDOSCOPE HRX MEDOS INTERNATIONAL SàRL 10886705026234

    Patients

    Seq Age Sex Outcome Treatment
    1