BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCK1 HD CAMERA HEAD

    MDR report key: 8594758 · Received May 9, 2019

    Report

    Report Number
    1221934-2019-57101
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 22, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FWF
    UDI-DI
    10886705026258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H10 ADDITIONAL NARRATIVE: 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 INTERMITTENT OPERATION OF THE DEVICE REPORTED BY THE CUSTOMER WAS CONFIRMED. UPON ANALYSIS, IT WAS FOUND THAT THE CAMERA CASTE WAS LOCALLY CHANGED BY THE CUSTOMER AND HENCE THE DEVICE CAN'T BE REPAIRED. THE DEVICE WAS SENT BACK WITHOUT REPAIR TO THE CUSTOMER. THE UNAUTHORIZED CHANGE OF THE CASTE OF THE CAMERA WOULD HAVE CAUSED THE DEVICE TO NOT FUNCTION AS INTENDED AND HENCE CAN BE HELD RESPONSIBLE FOR THE ISSUE EXPERIENCED BY THE CUSTOMER. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (242400) - LOT NUMBER (OM00327) COMBINATION PER QLIK QUERY EXECUTED 07/12/2019. 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).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 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.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN INDIA VIA E-MAIL THAT DURING LAPROSCOPY, IT WAS OBSERVED THAT THE IMAGE WOULD GO OFF COMPLETELY DURING MANIPULATION OF THE CAMERA; AND THEN THE GREEN INDICATOR THAT SHOWED THAT THE CAMERA WAS WORKING WOULD GO OFF WHEN THE IMAGE DISAPPEARED BUT THEN THE IMAGE WOULD COME ON AGAIN. IT WAS FURTHER REPORTED THAT THE BASE UNIT WOULD SOMETIME AUTOMATICALLY GO OFF ALTHOUGH THE IMAGE MAY STILL BE SEEN BUT THE PHOTO ALSO DID NOT GET CAPTURED. AS A RESULT, THERE WAS A SURGICAL DELAY OF HALF AN HOUR AS A STANDBY SYSTEM WAS AVAILABLE FOR USE. THE SURGERY WAS NOT COMPLETED AS THE DEVICE HAS SHIFTED FROM THE OTHER CENTER. 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
    388731 TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA FWF DEPUY MITEK LLC US 10886705026258

    Patients

    Seq Age Sex Outcome Treatment
    1