BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE, 4.0MM, 30 DEG, 175MM (STRYKER STYLE)

    MDR report key: 8942049 · Received August 28, 2019

    Report

    Report Number
    1221934-2019-58129
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 27, 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
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS SENT TO THE MANUFACTURER AND AN EVALUATION WAS PERFORMED. THE SALES REP REPORTED THE DEVICE AS HAVING DENTS IN THE SCOPE AND SCRATCHES, PER EVALUATION REPORT, THIS COMPLAINT CAN BE CONFIRMED. THE EVALUATION REVEALED THAT THERE WERE SCRATCHES ON THE DISTAL TIP, THE TUBE WAS DENTED, AND THE IMAGE WAS CLOUDY/FOGGY. THE OBJECTIVE WINDOW, TUBES AND FIBER OPTICS WERE REPLACED. INTERNAL SCOPE CLEANING WAS ALSO CARRIED OUT. THE DEVICE WAS REPAIRED AND FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. USER MISHANDLING IS THE LIKELY ROOT CAUSE OF THE REPORTED FAILURES. THE SERVICE HISTORY HAS BEEN REVIEWED IN LIEU OF THE DEVICE HISTORY RECORD FOR THIS DEVICE SINCE IT WAS PREVIOUSLY SERVICED. THE DEVICE WAS LAST SERVICED ON 06/26/2019 AND PASSED ALL FUNCTIONAL TESTING BEFORE BEING RETURNED TO THE CUSTOMER. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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. UDI: (B)(4). DEVICE HISTORY LOT : THE SERVICE HISTORY HAS BEEN REVIEWED IN LIEU OF THE DEVICE HISTORY RECORD FOR THIS DEVICE SINCE IT WAS PREVIOUSLY SERVICED. THE DEVICE WAS LAST SERVICED ON 06/26/2019 AND PASSED ALL FUNCTIONAL TESTING BEFORE BEING RETURNED TO THE CUSTOMER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT UPON INSPECTION OF THE ARTHROSCOPE 4/140 30 QIK/STRIKER HUB ARRIVING THERE ARE DENTS IN THE SCOPE AND SCRATCHES. THE UNIT WAS NOT USED IN A CASE AND THEREFORE NO PATIENT HARM OR DELAY IN A CASE WAS CAUSED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736435 ARTHROSCOPE, 4.0MM, 30 DEG, 175MM (STRYKER STYLE) RIGID ENDOSCOPE HRX MEDOS INTERNATIONAL SàRL 242043 23982 10886705026234

    Patients

    Seq Age Sex Outcome Treatment
    1