BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 18130108 · Received November 14, 2023

    Report

    Report Number
    9610595-2023-17130
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 11, 2023
    Report Date
    July 31, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED AS NO SERIAL/LOT INFORMATION WAS PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE CONNECTOR MISSING WAS THE DEVICE WAS REPROCESSED WITH THE DIFFERENT PROCEDURE FROM THE INSTRUCTION MANUAL. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT THE INITIAL MEDWATCH. THE DEVICE IDENTIFICATION INFORMATION PREVIOUSLY PROVIDED CONFLICTS WITH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID). GOOD FAITH ATTEMPTS WERE COMPLETED TO COLLECT THE SPECIFIC DEVICE MODEL NUMBER AND SERIAL NUMBER; HOWEVER, THE CUSTOMER RESPONSES WERE "UNKNOWN". AS A RESULT, THIS REPORT REFLECTS A REPRESENTATIVE SCOPE USED BY THE USER FACILITY BASED ON SHIPPING RECORDS. NO UPDATES WERE MADE TO D3 SINCE AIZU OLYMPUS CO., LTD. IS THE CORRECT MANUFACTURING SITE FOR THIS REPRESENTATIVE DEVICE. ALL OTHER FIELDS WERE UNKNOWN AS THE INFORMATION WAS NOT SPECIFIED BY THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE 2-CLAW CONNECTOR HAD COME OFF AND WAS MISSING. THERE WAS A RISK OF REPROCESSING FAILURE. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041816 UNKNOWN UNKNOWN FDS AIZU OLYMPUS CO., LTD. UNKNOWN
    354317 UNKNOWN UNKNOWN FDS AIZU OLYMPUS CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OER-3 SERIAL NUMBER (B)(6).