BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 8121413 · Received November 30, 2018

    Report

    Report Number
    1221934-2018-55486
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    July 31, 2018
    Report Date
    October 22, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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 SERVICE CENTER AND EVALUATED. THE COMPLAINT IS CONFIRMED. AS PER THE SERVICE REPORT IT IS CHECKED AND FOUND THE CAMERA HEAD IS NOT SENSED BY CCU AND COMPLAINT DEVICE IS NOT REPAIRABLE. THE ROOT CAUSE FOR THE REPORTED PROBLEM IS UNDETERMINED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER 242400, SERIAL NUMBER (B)(4) COMBINATION. 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). CORRECTED DATA: DATE DEVICE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PRE-SURGERY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CAMERA HEAD DEVICE WAS NOT GETTING DETECTED ON SWITCHING ON THE CCU AND MONITOR. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED IF THE PROCEDURE WAS COMPLETED. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 18NOVEMBER2018: THE ISSUES WAS DETECTED PRE-OPERATIVELY ON (B)(6) 2018. THERE WAS NO PROCEDURE OR PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958395 TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SàRL 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1