BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBT_BUTTON_4.0,167CW_MITEK

    MDR report key: 12422153 · Received September 3, 2021

    Report

    Report Number
    1221934-2021-02631
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 18, 2021
    Report Date
    August 24, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NBH
    UDI-DI
    10886705029174
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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: THE OBT_BUTTON_4.0,167CW_MITEK (PART #: 242258, LOT #: 1600901) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, NO VISUAL DEFECTS WERE OBSERVED WITH THE DEVICE, A FUNCTIONAL TEST WAS NOT PERFORMED ON THE RETURNED DEVICE AS IT WAS RETURNED BY ITSELF. HOWEVER, THE VIDEO SHOWED THAT THE DEVICE WAS UNABLE TO ASSEMBLE WITH THE MATING DEVICE. THEREFORE, THE COMPLAINT CONDITION FOR DEVICE INTERACTION COULD BE CONFIRMED BASED ON THE PROVIDED VIDEO BY THE CUSTOMER. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PROBLEM. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (4L23978), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    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

    ADDITIONAL NARRATIVE: 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 SALES REP IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE OBTURATOR_BUTTON_4.0,167CW_MITEK DEVICE WAS BENT THAT IT WOULD NOT PASS THROUGH ITS SHEATH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318861 OBT_BUTTON_4.0,167CW_MITEK RIGID ENDOSCOPE OBTURATOR NBH MEDOS INTERNATIONAL SARL 242258 1600901 10886705029174

    Patients

    Seq Age Sex Outcome Treatment
    1