BEUDAMED
    FDA Adverse Event Injury Summary report: N

    17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET

    MDR report key: 18331052 · Received December 14, 2023

    Report

    Report Number
    1216677-2023-00161
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 23, 2023
    Report Date
    February 1, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQE
    UDI-DI
    30888937021074
    PMA / PMN Number
    K000628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: FRANCE. CUSTOMER HAS STATED THAT THE DEVICE WAS NOT BEING RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 10-JAN-2023 UNDER WORK ORDER (B)(4) . MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED FOR PRODUCT ONS1733 AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS FOR ITEM ONS1733. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: FUNCTIONAL EVALUATION NOT APPLICABLE TO THIS COMPLAINT CONDITION. ROOT CAUSE : ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTIVE ACTIONS: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    PATIENT 2/2. IT WAS REPORTED THAT DURING AN OOCYTE RETRIEVAL, THE PATIENT SUFFERED A HEMOPERITONEUM. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS BEEN PROVIDED. ONS1733. 17G WALLACE OOCYTE RCVRY 2023-11-0000656.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113953 17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET IVF OOCYTE ASPIRATION NEEDLE, SINGLE-USE MQE COOPERSURGICAL, INC. ONS1733 619021140 30888937021074

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other