BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZINNANTI MANIPULATOR

    MDR report key: 6513083 · Received April 21, 2017

    Report

    Report Number
    1833117-2017-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    October 18, 2016
    Report Date
    April 4, 2017
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    LKF
    UDI-DI
    00852073002517
    PMA / PMN Number
    K974357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VERY RARE OCCURRENCE. A REVIEW OF THE RETURNED DEVICE PIECE CONFIRMED THE CLEAN BREAK. A CLEAN 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 INDICATE THAT SUCH FAILURE (CLEAN SHAFT SNAP IN THE VAGINA) 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.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE USER- FACILITY: "THE USER FACILITY REPORTED ON (B)(6) 2016 THAT THE PATIENT'S SPOUSE CALLED TO REPORT THAT THE PATIENT FELT A PLASTIC PIECE IN VAGINA. REPORTED A FOUR INCH SMALL PLASTIC PIECE WAS REMOVED. SURGEON WAS CALLED AND HE CONTACTED THE PATIENT. SPOKE WITH OR AND SAID IT WAS MOST LIKELY FROM THE HUMI (SIC) UTERINE MANIPULATOR. SPOKE WITH PATIENT . MET THEM AT SURGEON'S OFFICE, AND THEY PRESENTED THE PIECE WHICH HAS BEEN REMOVED. THE PIECE WAS A SEGMENT OF THE UTERINE MANIPULATOR. PATIENT INSTRUCTED TO OBSERVE FOR ANY OTHER CHANGES, SIGNS, OR SYMPTOMS AND TO CALL WITH ANY QUESTIONS AND CONCERNS. THE ORIGINAL INTENDED PROCEDURE WAS ROBOTIC SURGERY FOR OVARIAN CYST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291962 ZINNANTI MANIPULATOR CANNULA, MANIPULATOR, INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. TMI1151 Q374D 00852073002517

    Patients

    Seq Age Sex Outcome Treatment
    1 19.0 YR Other