BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 8782661 · Received July 11, 2019

    Report

    Report Number
    1221934-2019-57618
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 2, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 AND EVALUATED AT THE SERVICE CENTER. THE CUSTOMER REPORTED A MALFUNCTION, IT WAS FOUND THAT THE DEVICE DOES NOT DISPLAY VIDEO AND IMAGE SOMETIMES, THEREFORE WE CAN CONFIRM THIS COMPLAINT AS A DEFECT WAS FOUND WITH THE COMPLAINT DEVICE. THE CAMERA WAS FOUND TO BE DEFECTIVE BUT THE DEVICE WAS FOUND TO BE IRREPARABLE. THE DEVICE WAS RECYCLED IN ACCORDANCE WITH THE CUSTOMER'S INSTRUCTIONS. GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE DEFECTIVE CAMERA. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (242400) - LOT NUMBER (OM02122) COMBINATION PER QLIK QUERY EXECUTED (B)(4) 2019. 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA CST TOOL THAT THE HD CAMERA HEAD HAS A MALFUNCTION. THE CAUSE IS UNKNOWN. IT WAS UNKNOWN ABOUT THE PATIENT STATUS/ OUTCOME/ CONSEQUENCES. IT WAS UNKNOWN IF THERE WAS ANY MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) WAS REQUIRED OR WHETHER THE PATIENT WAS PART OF A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576283 TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SàRL 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1