MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number	CYF-5
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An olympus medical endoscopy support specialist performed a scope reprocessing in-service at the customer site as part of annual training.During the annual training, a staff member demonstrated reprocessing and the technician did not flush the device with detergent solution, water and air after the brush-cleaning was completed.The flushing steps are outlined in the device reprocessing manual.The device delivered a biopsy channel detachment error when it was being reprocessed in the device reprocessor.The endoscopy support specialist instructed the technician that if the scope were being sterilized, the flushing steps had to be performed.The technician repeated the demonstration of reprocessing with all required steps performed.The issue was resolved during observation.Once the facility inputted the correct model number, the error went away.No adverse effects to patient reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.While the olympus endoscope support specialist (ess) was on-site 29jun2023, the ess also observed that the facility doesn¿t use ethylene oxide (eto) and was advised to contact the manufacturer of that equipment for proper use.Additionally, the facility does have the mu-1 leak tester.The customer also understood that the olympus reprocessing manuals are the validated source of instructions.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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The event can be prevented by following the instructions for use (ifu) section which state: chapter 5 reprocessing the endoscope 5.5 manually cleaning the endoscope -flush the instrument channel with detergent solution olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Common Device Name: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17419869
• Report Number: 3002808148-2023-07704
• Device Sequence Number: 17928213
• Product Code: FAJ
• UDI-Device Identifier: 04953170434532
• UDI-Public: 04953170434532
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K221690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CYF-5
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2007
• 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
• Patient Sex: Unknown