BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUMI II KOH-EFFICIENT

    MDR report key: 19929087 · Received August 7, 2024

    Report

    Report Number
    1216677-2024-00035
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 24, 2024
    Report Date
    October 14, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    UDI-DI
    00888937015072
    PMA / PMN Number
    K954311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAD BEEN DISCARDED BY THE HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 12 OCT 2023. MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS, HOWEVER IN THOSE CASES THE COMPLAINT CONDITION WAS NOT CONFIRMED. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. ANY RELEVANT CUSTOMER OR CLINICAL INFORMATION: KC-SIZER WAS NOT USED PRIOR TO PERFORMING THE PROCEDURE. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IT SHOULD BE NOTED THAT THE IFU OF THE DEVICE ON PAGE 2, NUMBER 3 STATES THAT: USING THE SIZER, DETERMINE THE PROPER SIZE OF KOH-EFFICIENT. A POSSIBLE ROOT CAUSE OF THE FAILURE MAY BE ATTRIBUTED TO THE KC-SIZER NOT BEING USED AS NOTED IN THE FOLLOW-UP. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    PATIENT 2/5. IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, WHEN THE RUMI KOH-EFFICIENT WAS PLACED INTO THE VAGINA, IT CAUSED MAJOR VAGINAL LACERATIONS. DOCTOR IS CONCERNED THAT THE CUP IS DEFECTIVE. DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00035 KC-RUMI-30 KOH-EFFICIENT 2024-08-0000012.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219518 RUMI II KOH-EFFICIENT RUMI II KOH-EFFICIENT- 3.0 CM FOR USE WITH THE RUMI II HANDLE HEW COOPERSURGICAL, INC. KC-RUMI-30 339715 00888937015072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention