BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW UTERINE MANIPULATOR

    MDR report key: 19405174 · Received May 28, 2024

    Report

    Report Number
    1722684-2024-00009
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 21, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    LKF
    PMA / PMN Number
    K940681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DESCRIPTION: A DHR REVIEW WAS PERFORMED AND NO NCRS WERE FOUND TO BE INITIATED FOR LOT# 230245 RISK ASSESSMENT: PER FMEA-00125 [A] THE COMPLAINT MAY BE ASSOCIATED WITH THE FOLLOWING POTENTIAL FAILURE MODE: POTENTIAL FAILURE MODE: PULL OUT TEST RESULTS IN EXPOSURE OF THE STAINLESS STEEL SHAFT. HARM 1: DELAYED PROCEDURE SEVERITY: 1 POTENTIAL CAUSE: LACK OF ATTENTION, OPERATOR NOT FOLLOWED INSTRUCTIONS, INADEQUATE MANUFACTURING INSTRUCTIONS. PROBABILITY OF OCCURRENCE OF HARM: 1 RISK REGION: ACCEPTABLE HARM 2: LACERATION SEVERITY: 3 POTENTIAL CAUSE: LACK OF ATTENTION, OPERATOR NOT FOLLOWED INSTRUCTIONS, INADEQUATE MANUFACTURING INSTRUCTIONS. PROBABILITY OF OCCURRENCE OF HARM: 1 RISK REGION: ACCEPTABLE HARM 3: PERFORATION SEVERITY: 4 POTENTIAL CAUSE: LACK OF ATTENTION, OPERATOR NOT FOLLOWED INSTRUCTIONS, INADEQUATE MANUFACTURING INSTRUCTIONS. PROBABILITY OF OCCURRENCE OF HARM: 1 RISK REGION: MONITOR HARM 4: PERFORATION VESSEL SEVERITY: 4 POTENTIAL CAUSE: LACK OF ATTENTION, OPERATOR NOT FOLLOWED INSTRUCTIONS, INADEQUATE MANUFACTURING INSTRUCTIONS. PROBABILITY OF OCCURRENCE OF HARM: 1 RISK REGION: MONITOR ROOT CAUSE ANALYSIS A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. USER ERROR AND DEVICE MALFUNCTION CANNOT BE RULED OUT AS POTENTIAL ROOT CAUSES.

    Description of Event or Problem · 0

    TRANSLATED FROM DANISH USING GOOGLE TRANSLATE: "PT HAD A DISPOSABLE MANIPULATOR SITTING UP IN IT VAGINA AND UTERUS. WELL INTO THE OPERATION WILL THE DOCTOR DISCOVERS THAT IT IS BROKEN. WHEN THE MANIPULATOR IS BROKEN IS UNKNOWN. THE MANIPULATOR IS BROKEN IN THAT IT SMALL ROD THAT GOES UP THROUGH THE CERVIX AND INTO THE UTERUS HAS COME OFF THE ROD ITSELF - AND IS SITTING THUS STUCK UP IN THE UTERUS. FORTUNATELY, SITTING THERE ARE TWO HOSES ATTACHED TO THE ROD WHICH STICK OUT OF THE VAGINA + YOU CAN SEE THE BASE OF THE ROD. THIS IS A MANUFACTURING ERROR THE MANIPULATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664112 CLEARVIEW UTERINE MANIPULATOR UTERINE MANIPULATOR LKF CLINICAL INNOVATIONS, LLC UM700 230245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown