BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR / INJECTOR

    MDR report key: 6541490 · Received May 3, 2017

    Report

    Report Number
    1833117-2017-00003
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    February 24, 2017
    Report Date
    May 2, 2017
    Manufacturer
    CATHETER RESEARCH, INC
    Product Code
    LKF
    PMA / PMN Number
    K974357
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY MEDWATCH REPORT WAS SENT BY THE FDA TO THE MANUFACTURER. NO PRODUCT WAS RETURNED FOR ROOT CAUSE INVESTIGATION. A BREAK CAN BE THE RESULT OF SCORING OF SOME TYPE TO THE SHAFT OR STRESS CRACKING ON THE SHAFT. EACH DEVICE IS TESTED AND INSPECTED FOR STRESS CRACKING PRIOR TO RELEASE. A REVIEW OF THE RISK DOCUMENTS FOR USING THE DEVICE DOES SHOW THAT THE DEVICE BREAKING CAN ALSO BE CAUSED BY OVER MANIPULATION. WITH THE LIMIT AMOUNT OF INFORMATION KNOWN ON THE ROBOTIC PROCEDURE, IT IS VERY DIFFICULT TO DETERMINE THE TRUE CAUSE OF THIS FRACTURE. THE RISK ASSESSMENT PERFORMED ON THIS DEVICE ALSO INDICATES THAT SUCH FAILURE (BREAK IN THE VAGINAL CAVITY) WILL RESULT IN NUISANCE TO THE USER AND IS UNLIKELY TO CAUSE ANY SERIOUS INJURY. A REVIEW OF THE INSTRUCTIONS FOR USE INCLUDED WITH THE DEVICE SHOWS THE LAST STEP IS TO REMOVE THE DEVICE AND VERIFY THAT THE ENTIRE DEVICE WAS REMOVED INTACT AND NOTHING REMAINS BEHIND IN THE PATIENT. WE WILL CONTINUE TO MONITOR THIS ISSUE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    FROM THE USER FACILITY COMMENTS: "HUMI UTERINE MANIPULATOR BROKE DURING SURGERY WHILE THE FIRST ASSIST WAS MANIPULATING THE UTERUS. MANIPULATOR WAS REMOVED AND REPLACED BY SURGEON IN ORDER TO PROCEED WITH SURGERY. PART OF THE MANIPULATOR WAS LEFT IN THE VAGINA UNTIL RETRIEVED AT THE END OF THE SURGERY CASE. BOTH PIECES OF THE HUMI MANIPULATOR WERE REMOVED AT THE END OF CASE WITH NO HARM TO THE PATIENT. MANIPULATOR SAVED. HUMI WAS BROKEN AT THE END WHERE THE SYRINGE TUBING IS CONNECTED TO THE PLASTIC. (PLEASE NOTE: NO ALCOHOL WAS USED ON THIS PRODUCT.) WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ROBOTIC ASSIST RESECTION OF ENDOMETRIOSIS, LOA, FIMBRIOPLASTY, UREOLYSIS, APPENDECTOMY, TDS, CYSTO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320895 UTERINE MANIPULATOR / INJECTOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CATHETER RESEARCH, INC R671I

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other