MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fever (1858); Unspecified Infection (1930); Urinary Frequency (2275)

Event Type  Injury  

Event Description

The customer reported to olympus the facility had reprocessing errors and four 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 (b)(6) 1956 for cyf-vh, (b)(6): patient 2, dob (b)(6) 1939 for cyf-vh, (b)(6): patient 3, dob (b)(6) 1956 for cyf-vh, (b)(6): patient 4, dob (b)(6) 1957 for cyf-vh, (b)(6): patient 1, dob (b)(6) 1956 for maj-891, (b)(6): patient 2, dob (b)(6) 1939 for maj-891, (b)(6): patient 3, dob (b)(6) 1956 for maj-891, (b)(6): patient 4, dob (b)(6) 1957 for maj-891.This report is 3 of 8 for (b)(6): patient 3, dob (b)(6) 1956 for cyf-vh.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 15635565
• MDR Text Key: 302057909
• Report Number: 2429304-2022-00090
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/21/2022,10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAJ-891, UNKNOWN LOT.
• Patient Outcome(s): Other