BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW UTERINE MANIPULATOR

    MDR report key: 14518226 · Received May 26, 2022

    Report

    Report Number
    1722684-2022-00003
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 12, 2022
    Report Date
    May 26, 2022
    Manufacturer
    CLINICAL INNOVATIONS LLC
    Product Code
    LKF
    UDI-DI
    00814247020604
    PMA / PMN Number
    K940681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED. NO LOT NUMBER PROVIDED PER RISK-0006 REV. 02, THE COMPLAINT MAY BE ASSOCIATED WITH THE FOLLOWING POTENTIAL FAILURE MODE: POTENTIAL FAILURE MODE: USER FAILS TO REMOVE THE DEVICE FROM THE CERVICAL OS. POTENTIAL EFFECTS: DEVICE FRAGMENTS LEFT IN PATIENT. HARMS: FOREIGN BODY IN PATIENT. SEVERITY: 4. POTENTIAL CAUSE: LACK OF ATTENTION, NOT QUALIFIED PERSONNEL. PROBABILITY OF OCCURRENCE: 1. RISK IS CONSIDERED "MONITOR". NO ROOT CAUSE CAN BE DETERMINED

    Description of Event or Problem · 0

    IN THE CUSTOMERS WORDS: "THANK YOU FOR RETURNING MY CALL EARLIER WITH REGARDS TO THE ABOVE. AS I MENTIONED THIS WOULD BE THE SECOND TIME THIS TYPE OF INCIDENT HAS HAPPENED ON MY WATCH WITHIN THE LAST 2/3 YEARS. THE INCIDENTS ARE IDENTICAL IN THAT THE SPACER WAS LEFT INSIDE THE VAGINA OF BOTH PATIENTS AFTER THE MANIPULATOR HAD BEEN REMOVED. THE ASSUMPTION IS THAT THE SPACER IS CLICKED INTO PLACE BUT MAY DISLODGE WITH MOVEMENT WHILST BEING USED THEREFORE POTENTIALLY LEFT BEHIND. BOTH PATIENT HAD TO GO TO A&E TO HAVE THE FOREIGN BODY REMOVED. UNFORTUNATELY I DO NOT HAVE ANY LOT NUMBERS FOR ANY OF THE PRODUCTS AS THIS IS ONLY NOTICED A FEW DAYS AFTER THE PROCEDURE THEREFORE PRODUCT WILL ALREADY HAVE BEEN THROWN AWAY. THE 1ST I ENCOUNTERED THIS WAS AT (B)(6) HOSPITAL AND THE PRODUCT WAS EITHER THE UM700 OR UM900. THIS TIME I AM WORKING AT (B)(6) HOSPITAL AND THE PRODUCT USED WAS UM900 AS WE ONLY ORDER THE ONE PRODUCT. SINCE WE HAD THIS INCIDENT I WOULD LIKE TO REQUEST SOME TRAINING FOR MY STAFF AS EVIDENCE FOR THE PATIENT THAT SOMETHING HAS BEEN DONE TO PREVENT THIS FROM HAPPENING SOMEONE ELSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711602 CLEARVIEW UTERINE MANIPULATOR UTERINE MANIPULATOR LKF CLINICAL INNOVATIONS LLC UM900 UNKNOWN 00814247020604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown