BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 8114904 · Received November 29, 2018

    Report

    Report Number
    1221934-2018-55450
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    December 20, 2017
    Report Date
    November 28, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS SENT TO THE SERVICE CENTER FOR REPAIR. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS CONFIRMED REPORTED ISSUE OF DEVICE NOT WORKING CORRECTLY. THE DEVICE WOULD INTERMITTENTLY NOT DISPLAY VIDEO WHEN THE CABLE WAS MOVED, AND WHEN PRESSING THE "P" BUTTON WOULD ONLY INTERMITTENTLY RESPOND. DEVICE DISASSEMBLED AND DECONTAMINATED AS PER THE SERVICE MANUAL DURING INITIAL EVALUATION. 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. NO FURTHER INVESTIGATION BEYOND WHAT IS NOTED WILL BE CONDUCTED ON THIS COMPLAINT. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS FAILURE. THIS COMPLAINT CAN BE CONFIRMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING SET-UP FOR AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT THE VISUALIZATION CAMERA HEAD 242400 DEVICE FROM MX-TCK1 CAMERA EVAL KIT CODE 901286 WAS NOT WORKING PROPERLY. ACCORDING TO THE REPORTER, THE DEVICE DISPLAYED AN ERROR MESSAGE - POSSIBLE LOOSE CONNECTION WHEN IT WAS CONNECTED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD INTERMITTENTLY NOT DISPLAY VIDEO WHEN THE CABLE WAS MOVED; AND WOULD ONLY INTERMITTENTLY RESPOND WHEN PRESSING THE "P" BUTTON. THERE WAS NO SURGICAL DELAY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954603 TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA FWF DEPUY MITEK LLC US 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1