BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUMI II KOH-EFFICIENT

    MDR report key: 15649925 · Received October 20, 2022

    Report

    Report Number
    MW5112764
    Event Type
    Injury
    Date Received
    October 20, 2022
    Date of Event
    January 1, 2005
    Report Date
    October 6, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEAR FDA, THE RUMI UTERUS MANIPULATOR K954311 HAS A HUGE DESIGN MISTAKE THAT COULD LEAD TO MISUSE AND RUPTURE OF THE UTERUS. IT WAS MENTIONED IN A PAPER PUBLISHED IN 2005. AND I WAS SURPRISED THAT IN THE PRODUCT APPROVAL FORM THAT IS SUBMITTED TO YOU HTTPS://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/K954311.PDF LAST PAGE LAST PARAGRAPH "PERFORMANCE TEST" THAT THE BALLOON CAN HOLD 250 CC, WHY? THE UTERUS CAN HOLD 20-25 CC AND WILL RUPTURE. TWO CASES HAPPENED AND DOCUMENTED IN THE LITERATURE HTTPS://PUBMED.NCBI.NLM.NIH.GOV/15904626/ I CALL THIS DEVICE THE UTERU-DESTRUCTOR . IT SHOULD BE REDESIGNED ON THE PRINCIPLES OF POKA-YOKE WHETHER TO PREVENT THE BALLOON TO INFLATE THAT MUCH OR THE LINE PORT CONNECTED TO BALLOON SHOULD HAVE WARNING LABEL ATTACHED TO IT. I AM SURE HUNDRED OF WOMEN HAD THIS DESTRUCTIVE EXPERIENCE ALL AROUND THE WORLD. PLEASE DO SOMETHING ABOUT IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546278 RUMI II KOH-EFFICIENT CULDOSCOPE (AND ACCESSORIES) HEW COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Unknown Disability