MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ATTACHMENT, FOR CYF, 3-WAY STOPCOCK, QUICK LOCK; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number	A02908A
Medical Device Problem Codes	Device Reprocessing Problem (1091); Contamination (1120); Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Codes	Sepsis (2067); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the health care provider (hcp) noticed an increased number of urinary tract infections in patients after cystoscopy procedures when the facility started using the 3-way stopcock on flexible cystoscopes.There were four patients affected and the patients were admitted to the hospital the week after the procedure.They were diagnosed with urinary tract infection and sepsis.At first the stopcock devices were reprocessed using a thermal disinfector and now the facility reprocesses the device in the basket of an etd4 reprocessor.The customer indicated they had no instructions for machine cleaning the stopcock devices.The cystoscopes had a clear and proven washing process that had not been changed.It was when they changed to the new stopcock device that the urinary tract infections appeared, therefore it is the likely source of the infections.The customer indicated they did not know if the stopcocks had be cultured.Additional information regarding each individual patient outcome was requested but unknown by the customer.The customer indicated there were five stopcocks involved, however they could not trace which stopcock was used for each of the four individual patients that developed infection.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Per cleaning disinfection and sterilization (cds) processes checklist provided by the customer there have been deviations, deficiencies, and/or concerns in reprocessing.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the reported event occurred due to the device was not properly reprocessed and pathogens or other biological substances remained on the device.The event can be prevented by following the instructions for use which state: "stopcocks and tubing"."system guide endoscopy"."permissible reprocessing processes.Manual or automatic cleaning.Disinfection or high-level disinfection.Steam sterilization (autoclaving).Gas sterilization (eto)".Olympus will continue to monitor field performance for this device.

• Brand Name: ATTACHMENT, FOR CYF, 3-WAY STOPCOCK, QUICK LOCK
• Common Device Name: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20323237
• Report Number: 9610773-2024-02361
• Device Sequence Number: 8147243
• Product Code: GCP
• UDI-Device Identifier: 04042761019507
• UDI-Public: 04042761019507
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: A02908A
• Device Lot Number: 24305-0005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CYF-VHA CYSTO-NEPHRO VIDEOSCOPE.; ETD4 ENDOTHERMO DISINFECTOR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown