BEUDAMED
    FDA Adverse Event Injury Summary report: N

    17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET

    MDR report key: 18007470 · Received October 25, 2023

    Report

    Report Number
    1216677-2023-00141
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 20, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQE
    UDI-DI
    00888937021073
    PMA / PMN Number
    K000628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 05-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. FUNCTIONAL EVALUATION: FUNCTIONAL EVALUATION NOT APPLICABLE TO THIS COMPLAINT CONDITION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: ITALY, H3: DEVICE DISCARDED. CUSTOMER HAS STATED THAT THE PRODUCT DISCARDED AND CAN NOT BE RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    PATIENT 3/3 IT WAS REPORTED BY THE CUSTOMER THAT WHILE PERFORMING TRANSVAGINAL COLLECTION OF OOCYTES FROM THE OVARIAN FOLLICLES, USING AN OOCYTE RECOVERY NEEDLE, THE PATIENT EXPERIENCED COPIOUS BLEEDING. THE DOCTOR DETERMINED THAT THE PATIENT SUSTAINED A HEMOPERITONEUM OF OVARIAN ORIGIN AND REPAIRED VIA OPERATIVE LAPAROSCOPY. THE RECOVERY NEEDLE WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. ONS1733 17G OOCYTE RECOVERY 2023-10-0000471.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700696 17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET IVF OOCYTE ASPIRATION NEEDLE, SINGLE-USE MQE COOPERSURGICAL, INC. ONS1733 619020972 00888937021073

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention