BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHSCO,4/140_30_QIK/STRKR HUB

    MDR report key: 8480697 · Received April 3, 2019

    Report

    Report Number
    1221934-2019-56758
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 20, 2018
    Report Date
    March 29, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HRX
    UDI-DI
    10886705026234
    PMA / PMN Number
    K971996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [PRODUCT CODE: 242043, SERIAL NUMBER:(B)(4)], AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 WERE DAMAGED. THEREFORE, THE COMPLAINT CAN BE CONFIRMED. THE FOLLOWING REPAIR TASKS WERE COMPLETED TO RESTORE TO CORRECT SPECIFICATION: INTERNAL SCOPE CLEANING COMPLETED, REPLACED THE OBJECTIVE WINDOW, REPLACED THE OBJECTIVE, AUTOCLAVE SERVICE COMPLETE. THE ROOT CAUSE FOR THIS COMPLAINT CAN BE ATTRIBUTED TO REPEATED USE AND/OR IMPROPER HANDLING OF THE SCOPE BY THE END USER BUT A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. UDI: (B)(4).

    Description of Event or Problem · 1

    REP CALLING IN A SCOPE AFTER THE FACT NO TROUBLESHOOTING ALLOWED SCOPE HAS A SCRATCH IN LENS. FOUND IN SURGERY. SHOULDER SCOPE. NO DELAY. NO PATIENT HARM. CONTINUED WITH ANOTHER SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271873 ARTHSCO,4/140_30_QIK/STRKR HUB RIGID ENDOSCOPE HRX MEDOS INTERNATIONAL SARL 10886705026234

    Patients

    Seq Age Sex Outcome Treatment
    1