BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHSCO,4/140_30_QIK/STRKR HUB

    MDR report key: 8482479 · Received April 4, 2019

    Report

    Report Number
    1221934-2019-56760
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    December 5, 2018
    Report Date
    April 3, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HRX
    UDI-DI
    10886705026234
    PMA / PMN Number
    K971996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT SUPPLIER AND EVALUATED. FUNCTIONAL OBSERVATION REVEALED THAT THE IMAGE WAS CLOUDY OR FOGGY, RESULTING IN POOR IMAGE QUALITY WHEN VIEWING THROUGH THE EYEPIECE. ADDITIONALLY, THE TUBE WAS ALSO REPORTED BENT AND OPTICS, DISTAL TIP, OBJECTIVE, WINDOW WERE DAMAGED. THEREFORE THE COMPLAINT CAN BE CONFIRMED. THE ROOT CAUSE FOR THIS COMPLAINT CAN BE ATTRIBUTED TO REPEATED USE AND/OR IMPROPER HANDLING OF THE SCOPE BY THE END USER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [PRODUCT CODE: 242043, SERIAL NUMBER: (B)(4)] , AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE TWO ARTHROSCOPES 30 DEGREE HAD SCRATCHES ON THE LENS. THE CASE WAS COMPLETED BY USING ANOTHER SCOPE WITH NO PATIENT HARM OR DELAY. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277743 ARTHSCO,4/140_30_QIK/STRKR HUB RIGID ENDOSCOPE HRX MEDOS INTERNATIONAL SARL 10886705026234

    Patients

    Seq Age Sex Outcome Treatment
    1