BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 8460252 · Received March 28, 2019

    Report

    Report Number
    1221934-2019-56700
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    December 6, 2018
    Report Date
    March 26, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 DEVICE WAS RECEIVED AT SERVICE CENTER AND EVALUATED. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS CONFIRMED REPORTED ISSUE OF THE IMAGE CUTTING OUT. THE DEVICE WOULD INTERMITTENTLY NOT DISPLAY VIDEO OR WOULD DISPLAY POOR QUALITY VIDEO. HOWEVER,THE ROOT CAUSE FOR THE REPORTED FAILURE IS UNDETERMINED. THERE IS NO REPAIR AUTHORIZED FOR THIS DEVICE, SO THE DEVICE WILL BE PLACED INTO LONG TERM HOLD WITH NO FURTHER REPAIR ACTIVITIES TAKING PLACE. FURTHERMORE, NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (242400), SERIAL NUMBER ((B)(4)) COMBINATION. REVIEW CONDUCTED PER QLIK QUERY EXECUTED ON (B)(6)2019. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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 PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S TCK1 CAMERA HEAD HAD POOR IMAGE QUALITY AND THE IMAGE WAS CUTTING OUT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252188 TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SARL 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1