BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUMI II KOH-EFFICIENT

    MDR report key: 17774911 · Received September 19, 2023

    Report

    Report Number
    1216677-2023-00125
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 15, 2023
    Report Date
    November 20, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K954311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: NEW ZEALAND. CUSTOMER HAS INDICATED THAT THE PRODUCT WAS DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: A DISTRIBUTION HISTORY RECORD REVIEW WAS NOT POSSIBLE FOR THIS PRODUCT AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED FOR INVESTIGATION MANUFACTURING RECORD REVIEW: A DHR REVIEW WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. 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. 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 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 E-MAIL. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE ROOT CAUSE CANNOT BE RELIABLY DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, A DIFFERENT SIZE RUMI KOH WAS CHOSEN AND THEN INSERTED BY THE GYNAE CONSULTANT. THE RUMI KOH USED IN THIS CASE WAS A 3.5. AT THE END OF THE PROCEDURE VAGINAL BLEEDING WAS NOTED AND PACKING AND SNOW WAS INSERTED. THIS WAS STILL BLEEDING AN HOUR LATER AND PATIENT RETURNED TO THEATRE. TWO VAGINAL TEARS WERE FOUND - 3CM AND 3.5CM DIRECTLY OPPOSITE FROM EACH OTHER AND NEEDED TO BE REPAIRED. NO ADDITIONAL INFORMATION AVAILABLE. (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062159 RUMI II KOH-EFFICIENT COLPOTOMY TUBE HEW COOPERSURGICAL, INC. KC-RUMI-35 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention