BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II KOH-EFFICIENT

    MDR report key: 6411897 · Received March 16, 2017

    Report

    Report Number
    1216677-2017-00011
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    December 21, 2016
    Report Date
    March 31, 2017
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K954311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED YET BY CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE COMPLAINT: E-COMPLAINT-(B)(4). UPDATE: INVESTIGATION: DHR REVIEW FOR PRODUCT NO. KCS-RUMI-30 (KOH-EFFICIENT, RUMI 3.0 CM), LOT NO. 200800 MANUFACTURED/TESTED DURING FEB 2016 SHOWS THAT ALL PRODUCTS WERE MANUFACTURED AND TESTED PER ESTABLISHED PROCEDURES AT LONE STAR. DURING KCS-RUMI WORK ORDER, ALL ARE SUBJECTED TO IN-PROCESS TESTING TO A PULL TEST OF 10 LBS, AND THERE WERE NO REJECTIONS OBSERVED. ALL ASSEMBLIES MET THE 10 LBF MINIMUM PULL-FORCE SPECIFICATION. ADDITIONALLY, A RANDOM SAMPLE OF FIVE FROM THE WORK ORDER WAS INSPECTED BY QC, ALSO SUBJECTING THE ASSEMBLIES TO THE FUNCTIONAL PULL TEST OF 10 LBF MINIMUM PULL FORCE, AND NONE WERE REJECTED. NO SAMPLES WERE RETURNED, SO A ROOT CAUSE INVESTIGATION WAS NOT POSSIBLE. WITHOUT THE UNIT, IT IS UNKNOWN HOW THE UNIT BROKE AS DESCRIBED IN THE COMPLAINT. A COMPLAINT HISTORY RECORD REVIEW WAS PERFORMED AND FOUND THAT THE LOT 200800 HAD ANOTHER COMPLAINT (B)(4) WHERE A CUP WAS DETACHED DUE TO GLUE BOND COMPROMISED BY HINGE BREAKING. THE CORRECTIVE ACTION TAKEN SINCE WAS TO IMPLEMENT A BENDING MOMENT TEST (VALIDATED PER VMP-16-0088), TESTING EACH OF THE RUMI ASSEMBLIES AT 12-13 IN-LBS DURING IN PROCESS INSPECTION, SUBSEQUENTLY FOLLOWED BY A 10 LBF FUNCTIONAL PULL TEST. QC INSPECTION INVOLVED TESTING 20 UNITS SAMPLED RANDOMLY FROM THE WORK ORDER. CORRECTIVE ACTIONS: A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT AS UNIT WAS NOT RETURNED FOR ROOT CAUSE INVESTIGATION. COMPLAINT INCIDENCE WILL BE MONITORED AND TRENDED.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED YET BY CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PER MEDWATCH MW5067074. "AFTER RUMI HANDLE 3.0 WAS PLACED IN CERVIX, THE DEVICE DELL INTO TWO PIECES. ALL ITEMS ACCOUNTED FOR AND NEW DEVICE WAS PLACED."

    Description of Event or Problem · 1

    PER MEDWATCH MW5067074. "AFTER RUMI HANDLE 3.0 WAS PLACED IN CERVIX, THE DEVICE DELL INTO TWO PIECES. ALL ITEMS ACCOUNTED FOR AND NEW DEVICE WAS PLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194200 RUMI II KOH-EFFICIENT UTERINE MANIPULATOR LKF COOPERSURGICAL, INC. KCS-RUMI-30 200800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention