BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    242326

    MDR report key: 9595908 · Received January 16, 2020

    Report

    Report Number
    1221934-2020-00224
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 17, 2019
    Report Date
    December 17, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FCW
    UDI-DI
    00817613020543
    PMA / PMN Number
    K123359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: CORRECTION: UPON COMPLAINT REVIEW, IT WAS DETERMINED THAT MFR# 1221934-2020-00224 IS A DUPLICATE OF MFR# 1221934-2020-00249. REFERENCE MFR # 1221934-2020-00249 FOR ALL FURTHER REPORTING REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE MITEK VIDEO CART WAS SET UP AND WHEN THE LIGHT CORD AND CAMERA WERE PLUGGED IN, THE MONITOR AND EVO4K STARTED TO DISPLAY A NUMBER OF COLORS IN STATIC FORMAT. THE CAMERA CORD WAS PULLED OUT AND PLUGGED BACK IN - SAME STATIC PICTURE DISPLAYED. A REPLACEMENT CAMERA WAS USED AND DISPLAYED THE SAME RESULT. THE MONITOR WAS POWERED OFF/ON AND THE STATIC COLOR SCHEME WAS STILL PRESENT. FINALLY, THE CCS WAS POWERED OFF WHILE CONFIRMING ALL WIRING IN THE BACK WAS CORRECT AND CONNECTED PROPERLY. THE CCS WAS POWERED BACK ON AND CAMERA/LIGHT CORD PLUGGED BACK IN. ONCE AGAIN THE STATIC COLOR SCHEME REAPPEARED. THE COMPETITIVE TOWER, IN THE ROOM, WAS POWERED ON AND WAS USED FOR VIDEO ON THE CASE. OUR PUMP AND SHAVER CONTINUED TO BE USED FROM THE PUREVUE TOWER. THERE WAS A MINIMAL DELAY (UNDER 3 MINUTES) TO CONNECT NEW VIDEO. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59311 242326 EVOLUTION4K FCW DEPUY MITEK LLC US Evo4K220 00817613020543

    Patients

    Seq Age Sex Outcome Treatment
    1