BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMI

    MDR report key: 6533224 · Received May 1, 2017

    Report

    Report Number
    1833117-2017-00002
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    January 19, 2017
    Report Date
    April 28, 2017
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    LKF
    PMA / PMN Number
    K974357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REVIEWED DATA (PHOTOS OF THE DEVICE BREAKAGE WERE PROVIDED BUT DEVICE WAS NOT PROVIDED AS IT WAS SENT TO DISTRIBUTOR WITHOUT BEING DECONTAMINATED), THE BREAK POINT OF THE CATHETER AT THE BASE OF THE HANDLE APPEARS TO BE A CLEAN BREAK AT APPROX. 9 CM MARK BY THE CERVICAL STOP. THIS INDICATES THAT THE BREAKAGE OCCURRED IN THE VAGINAL CAVITY AND COULD NOT OCCUR INSIDE THE UTERUS AS ORIGINALLY REPORTED. STRESS CRACK - KNOWN TO OCCUR ON RIGID PVC COULD BE THE CAUSE OF THE SHAFT BREAKAGE. ALL PRODUCTS ARE 100% INSPECTED AND BEND TESTED BEFORE RELEASE. WE BELIEVE THIS TO BE AN ISOLATED INCIDENT AND WILL CONTINUE TO MONITOR. NO FURTHER PRODUCT ACTION IS PRESENTLY REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: "THE UTERINE TIP SNAPPED OFF INSIDE THE PATIENT'S UTERUS WHILE BEING MANIPULATED BY THE SURGEON. LITTLE FORCE WAS APPLIED DURING MANIPULATION AND THE BROKEN PIECES WAS REMOVED SAFELY AND NOT PATIENT HARM." PATIENT CONDITION: NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314628 PUMI CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. 600243-001 L708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other