BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUMI II KOH-EFFICIENT

    MDR report key: 18717314 · Received February 15, 2024

    Report

    Report Number
    1216677-2024-00004
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 28, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: JAPAN. THE CUSTOMER HAS INDICATED THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION. 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 DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS RETURNED TO COOPERSURGICAL ON 01/30/2024. VISUAL EVALUATION: VISUAL EVALUATION OF THE PRODUCT SHOWS THAT THE PRODUCT HAS MELTED. IT WAS ALSO NOTICED THAT THE PRODUCT WAS MISSING THE OCCLUDE BALLOON. FUNCTIONAL EVALUATION: FUNCTIONAL EVALUATION NOT APPLICABLE FOR THIS COMPLAINT CONDITION. ROOT CAUSE: BASED ON THE VISUAL INVESTIGATION, IT IS POSSIBLE THAT THE PRODUCT WAS USED WITH A HARMONIC OR OTHER TYPES OF ULTRASONIC OR LASER, CAUSING THE PRODUCT TO MELT AND LEAVE FRAGMENTS. POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO IMPROPER USAGE OF THE DEVICE WHICH LEAD TO THE MELTING OF THE CUP (MADE FROM ULTEM). THE KC-RUMI LINE OF PRODUCTS IS NOT INTENDED TO BE USED WITH A HARMONIC OR OTHER TYPES OF ULTRASONIC OR LASER, THIS IS MENTIONED IN THE IFU (RUMI-II-KOH-EFFICIENT-IFU) UNDER THE WARNINGS SECTION. CORRECTIVE ACTIONS: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT WAS NOT MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FRAGMENT OF KOH CUP RESIN WAS FOUND IN THE ABDOMINAL CAVITY WHILE CLEANING IN TLH TREATMENT. THE DOCTOR ASKS WHAT WILL HAPPEN IF THE FRAGMENTS OF RESIN ARE NOT COLLECTED. IT IS REPORTABLE IN JAPAN. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00004 KC-RUMI-30 KOH-EFFICIENT 2024-01-0000404.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991201 RUMI II KOH-EFFICIENT KOH-EFFICIENT,RUMI,3.0CM HEW COOPERSURGICAL, INC. KC-RUMI-30 UNKNOWN 00888937015072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention