BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBT_BUTTON_4.0,167CW_MITEK

    MDR report key: 11507117 · Received March 17, 2021

    Report

    Report Number
    1221934-2021-00877
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 3, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NBH
    UDI-DI
    10886705029174
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. INVESTIGATION SUMMARY : IT WAS REPORTED BY THE CUSTOMER VIA PHONE THAT THE DUAL STOPCOCK SHEATH 5.9MM X 30 DEG X 167MM (MITEK LOCK) AND THE OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) ARE BENT TOGETHER AND WOULD NOT COME APART EASILY. NO PROCEDURE OR PATIENT INVOLVEMENT. THESE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION. INVESTIGATION: OBT_BUTTON_4.0,167CW_MITEK (PART# 242258, LOT# 1530729, QTY# 1) WAS RETURNED AND RECEIVED AT US CQ. VISUAL INSPECTIONS REVEALED THAT THE SHAFT PART OF THE DEVICE GOT SLIGHTLY BENT. THE BENT SHAFT MIGHT HAVE CONTRIBUTED TO THE REPORTED UNABLE TO DISASSEMBLE CONDITION. THE SURFACE OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. FUNCTIONAL TEST CANNOT BE PERFORMED AT CQ AS THE MATING DEVICES WERE NOT RETURNED AT CQ. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THIS FAILURE REPORTED CAN BE RELATED TO THE WEAR AND TEAR OF THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS REVIEWED, NO NON-CONFORMANCES WERE IDENTIFIED FOR THE REPORTED PART 242258- LOT 1530729 NUMBER COMBINATION. 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. THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. D9: THE DATE DEVICE RETURNED TO MANUFACTURER HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. H10 ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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

    UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK) DEVICE WAS BENT AND WOULD NOT COME APART EASILY WITH THE STOPCOCK DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406045 OBT_BUTTON_4.0,167CW_MITEK RIGID ENDOSCOPE OBTURATOR NBH MEDOS INTERNATIONAL SARL 242258 1530729 10886705029174

    Patients

    Seq Age Sex Outcome Treatment
    1