BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)

    MDR report key: 15639723 · Received October 20, 2022

    Report

    Report Number
    9610595-2022-03120
    Event Type
    Injury
    Date Received
    October 20, 2022
    Report Date
    December 6, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    UDI-DI
    04953170063114
    PMA / PMN Number
    K912120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304 - 2022 - 00094.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL/LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE PATIENT INFECTIONS COULD NOT BE DETERMINED. HOWEVER, IT WAS CONFIRMED THAT THE SUBJECT DEVICE (MAJ-891) WAS NOT BEING COMPLETELY DISASSEMBLED DURING REPROCESSING OF THE ACCESSORY. ALSO, DISINFECTANT WAS ONLY CHECKED ONCE A DAY. IT IS LIKELY THAT THE USER DID NOT FOLLOW OLYMPUS¿S RECOMMENDATIONS FOR HANDLING AND REPROCESSING OF THE DEVICE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿DISASSEMBLING THE FORCEPS/IRRIGATION PLUG; BE SURE TO DISASSEMBLE THE FORCEPS/IRRIGATION PLUG BEFORE IT IS CLEANED, DISINFECTED, OR STERILIZED. OTHERWISE, THE FORCEPS/IRRIGATION PLUG MAY NOT BE PROPERLY CLEANED/DISINFECTED/STERILIZED.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE FACILITY HAD REPROCESSING ERRORS AND FOUR (4) PATIENT INFECTIONS AFTER CYSTOSCOPY PROCEDURES BETWEEN (B)(6) 2022. THE PATIENTS EXHIBITED FEVER AND URINARY FREQUENCY. THE PATIENTS' URINE WAS CULTURED AND THE RESULTS WERE POSITIVE FOR PSEUDOMONAS. THE ENDOSCOPE WAS NOT TESTED FOR MICROBIAL CONTAMINATION. CUSTOMER REQUESTED A REPROCESSING IN-SERVICE WITH OBSERVATION. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) PERFORMED THE IN-SERVICE WHICH INCLUDED CLEANING, DISINFECTION, AND STERILIZATION INFORMATION CONTAINED IN THE OLYMPUS MANUAL. THE ESS IDENTIFIED THE FOLLOWING REPROCESSING ERRORS: THE LEAK TEST WAS NOT BEING PERFORMED WITH THE ENDOSCOPE SUBMERGED IN WATER, THE FORCEPS/IRRIGATION PLUG (MAJ-891) WAS NOT BEING COMPLETELY DISASSEMBLED DURING REPROCESSING, THE MINIMUM RECOMMENDED CONCENTRATION OF THE DISINFECTANT WAS ONLY BEING CHECKED ONCE A DAY. THE ESS PROVIDED REPROCESSING WALL CHARTS TO THE CUSTOMER FOR FLEXIBLE ENDOSCOPE CLEANING & DISINFECTION AND REPROCESSING FLEXIBLE ENDOSCOPE ACCESSORIES. THE CUSTOMER REPORTED THE FOLLOWING PROCEDURE DATES BUT DID NOT SPECIFY WHICH PATIENT PROCEDURE WAS PERFORMED ON THE SPECIFIC DATE: (B)(6) 2022 (ONE PATIENT), (B)(6) 2022 (ONE PATIENT), (B)(6) 2022 (TWO PATIENTS). THIS EVENT INCLUDES 8 REPORTS FOR FOUR PATIENTS AND TWO OLYMPUS DEVICES. (B)(6): PATIENT 1, DOB 09/12/1956 FOR CYF-VH. (B)(6): PATIENT 2, DOB 07/17/1939 FOR CYF-VH. (B)(6): PATIENT 3, DOB 02/14/1956 FOR CYF-VH. (B)(6): PATIENT 4, DOB 05/29/1957 FOR CYF-VH. (B)(6): PATIENT 1, DOB 09/12/1956 FOR MAJ-891. (B)(6): PATIENT 2, DOB 07/17/1939 FOR MAJ-891. (B)(6): PATIENT 3, DOB 02/14/1956 FOR MAJ-891. (B)(6): PATIENT 4, DOB 05/29/1957 FOR MAJ-891. THIS REPORT IS 7 OF 8 FOR (B)(6): PATIENT 3, DOB 02/14/1956 FOR MAJ-891.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820094 FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG FGB AIZU OLYMPUS CO., LTD. MAJ-891 UNKNOWN 04953170063114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CYF-VH, SERIAL (B)(6)