BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUMI II KOH-EFFICIENT

    MDR report key: 19960424 · Received August 12, 2024

    Report

    Report Number
    1216677-2024-00033
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 15, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: JAPAN. DEVICE LOCATION IS UNKNOWN. 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 LOT NUMBER WAS NOT PROVIDED FOR INVESTIGATION. MANUF. RECORD REVIEW: A DHR REVIEW WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. 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: 1. LOT NUMBER WAS NOT PROVIDED STATING THAT: THE PRODUCT ITSELF HAS NOT BEEN FOUND TO BE DEFECTIVE. 2. KC-SIZER WAS 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 IS TO BE NOTED THAT THE COMPLAINANT ACKNOWLEDGES THAT THE PRODUCT ITSELF WAS NOT FOUND TO BE DEFECTIVE. NO LOT NUMBER WAS PROVIDED FOR INVESTIGATION; HOWEVER, WE PERFORMED OUR INVESTIGATION TO FIND OUT ALL LOT NUMBERS FOR KC-RUMI-30 SHIPPED TO (B)(6) JAPAN (CSI DISTRIBUTION FACILITY IN JAPAN) IN PAST 3 YEARS. BASED ON FURTHER REVIEW, NO NCMRS WERE IDENTIFIED FOR THE LISTED LOT NUMBER FOR FLASH/SHARP EDGES THAT MAY POTENTIALLY CAUSE LACERATION. 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

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RUMI KOH-EFFICIENT WAS USED AND LACERATED THE VAGINAL WALL. NO OBVIOUS DEFECT IN THE DEVICE WAS FOUND. SUTURES WERE REQUIRED TO STOP BLEEDING. NO ADDITIONAL INFORMATION IS AVAILABLE. KC-RUMI-30 KOH-EFFICIENT (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779527 RUMI II KOH-EFFICIENT KOH-EFFICIENT,RUMI,3.0CM BOX OF 5 HEW COOPERSURGICAL, INC. KC-RUMI-30 UNKNOWN 00888937015072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention