BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFF,RUMI,3.0CM,HARMNC

    MDR report key: 7960656 · Received October 12, 2018

    Report

    Report Number
    1216677-2018-00056
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    October 11, 2018
    Report Date
    March 16, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    UDI-DI
    00888937015119
    PMA / PMN Number
    K954311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION: NO SAMPLE RETURNED. REVIEW DHR. ANALYSIS AND FINDINGS: DHR REVIEW FOR PRODUCT NO. KCS-RUMI-30 (KOH-EFFICIENT, RUMI 3.0 CM), LOT (B)(6) MANUFACTURED/TESTED DURING FEB 2018 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 TORQUE TEST AND SUBSEQUENTLY FOLLOWED BY A PULL TEST OF 10 LBS, AND THERE WERE NO REJECTIONS OBSERVED. ALL ASSEMBLIES MET THE 11-13 IN-LBF TORQUE TEST, AND AS WELL AS 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 AS PERFORMED NO SIMILAR OCCURRENCES OF COMPLAINT CONDITION WAS FOUND FROM THE SAME LOT. HOWEVER, THERE WERE OTHER COMPLAINTS OF SIMILAR CONDITION FROM OTHER WORK ORDERS. 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. CORRECTION AND/OR CORRECTIVE ACTION: 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. UNIT WAS NOT RETURNED INVESTIGATE FURTHER FOR ANY OTHER MANUFACTURING ISSUES. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    THE DEVICE HAS BROKEN DURING THE PROCEDURE, AND THE BROKEN PART (THE CUP) WAS STUCK IN THE PATIENT'S VAGINA. RISK OF PERFORATION. THE PROCEDURE HAS BEEN STOPPED. 1216677-2018-00056-1 KOH-EFF RUMI 3CM HARMNC KCS-RUMI-30 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT IS EXPECTED TO BE RETURNED FOR EVALUATION BY CUSTOMER. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "ROBOT ASSISTED HYSTERECTOMY - THE DEVICE HAS BROKEN DURING THE PROCEDURE, AND THE BROKEN PART (THE CUP) WAS STUCK IN THE PATIENT'S VAGINA. RISK OF PERFORATION. THE PROCEDURE HAS BEEN STOPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803673 KOH-EFF,RUMI,3.0CM,HARMNC KOH-EFF,RUMI,3.0CM,HARMNC HEW COOPERSURGICAL, INC. KCS-RUMI-30 243215 00888937015119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O