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 AND (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 OLYMPUSENDOSCOPY 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 5 OF 8 FOR (B)(6): PATIENT 1, DOB (B)(6) 1956 FOR (B)(4).