BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 7145263 · Received December 24, 2017

    Report

    Report Number
    1221934-2017-50099
    Event Type
    Malfunction
    Date Received
    December 24, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 23, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.¿ (B)(4).

    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. EVALUATION STATEMENT: THE DEVICE WAS RECEIVED AT THE SERVICE CENTER. THE COMPLAINT WAS CONFIRMED. THE DEVICE WAS FOUND TO BE IRREPARABLE, THEREFORE IT WAS NOT SERVICED. THE FOLLOWING INFORMATION WAS DERIVED FROM THE SERVICE REPORT: INTERMITTENT WORKING AND SHOWING ERROR MSG. CHECKED & FOUND THE CAMERA DISPLAY IS NOT STABLE. WHEN THE CAMERA DISPLAY IS NOT STABLE, THE DEVICE WILL OPERATE INTERMITTENTLY THEREFORE IS A ROOT CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED. AT THIS POINT, 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. (B)(4).

    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. UDI: (B)(4).

    Description of Event or Problem · 1

    IMAGE WAS DISCONTINUOUS. INTERMITTENT IMAGE LOSS DURING SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 05NOVEMBER2018: REPORTEDLY THERE WAS NO CONSEQUENCE TO THE PATIENT. THE SURGERY WAS DELAYED ABOUT TWO TO THREE HOURS. THE ISSUE WAS ON DEVICES ON (B)(6) 2017 DURING AN ADENOIDECTOMY PROCEDURE. IT WAS NOTED THE USER WAS TRAINED. THERE WERE NO ACTIONS TAKEN TO MANAGE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924266 TCK1 HD CAMERA HEAD TCK1 HD CAMERA HEAD FWF DEPUY MITEK 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1