BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW UTERINE MANIPULATOR

    MDR report key: 19514670 · Received June 11, 2024

    Report

    Report Number
    1722684-2024-00010
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 11, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    LKF
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DESCRIPTION THE LOT NUMBER IS UNKNOWN, THEREFORE, THE NUMBER OF MFG CAUSED DEVICES FIELD AND DHR REVIEW SECTION WILL REMAIN BLANK. RISK ASSESSMENT PER FMEA-00126 [A], THE COMPLAINT MAY BE RELATED TO THE FOLLOWING POTENTIAL FAILURE MODE: POTENTIAL FAILURE MODE: FAILURE TO SECURE SPACER APPROPRIATELY. POTENTIAL EFFECTS: SPACER IS RETAINED IN THE VAGINA. HARM: FOREIGN BODY IN PATIENT SEVERITY: 4 POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL PROBABILITY OF OCCURRENCE OF HARM: 1 INITIAL RISK REGION: MONITOR NO ROOT CAUSE COULD BE DETERMINED, NO DEVICE WAS RETURNED, IT WAS DISPOSED BY USER FACILITY THE SPECIFIC DEVICE WITHIN THE CLEARVIEW FAMILY IS UKNOWN, THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE COULD EITHER BE CLEARVIEW OR CLEARVIEW TOTAL, SEE BOTH 510K NUMBERS BELOW. CLEARVIEW- K940681 CLEARVIEWTOTAL- K131781.

    Description of Event or Problem · 0

    IN THE CUSTOMERS WORDS: " IN ADDITION, I HAVE A CASE TO SHARE WITH YOU. WE HAVE RECEIVED THE FOLLOWING ACCIDENT REPORT FROM THE HOSPITAL RECENTLY. DATE INFORMATION RECEIVED: MAY 8, 2024. DATE OF OCCURRENCE: (B)(6) 2024. WHAT HAPPENED: AFTER SURGERY USING A UTERINE MANIPULATOR, THE SPACER REMAINED INSIDE THE PATIENT'S BODY AND BECAME INFECTED. WHEN THE PATIENT WENT TO A NEARBY CLINIC FOR ABDOMINAL PAIN, THE SPACER WAS FOUND, AND REMOVAL SURGERY WAS PERFORMED. INTERNAL CLAIM NUMBER: (B)(4). WE DON'T KNOW WHETHER THIS IS A PRODUCT MATTER OR A USAGE MATTER YET.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163955 CLEARVIEW UTERINE MANIPULATOR UTERINE MANIPULATOR LKF CLINICAL INNOVATIONS, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention