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

Model Number CYF-5

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

During the on-site evaluation, the olympus endoscopy support specialist (ess) gave a "cleaned, disinfected, and sterilized" (cds) in-service at the facility to the staff.The ess demonstrated proper reprocessing steps, beginning with pre-cleaning at the bedside through high-level disinfection.Ess emailed the completed attendance sheet and "ontracks" to the office manager at the facility.Ess had recommended that the customer purchase a handheld leak tester to perform the recommended leak test prior to washing all scopes, purchase the appropriate size basin for reprocessing, purchase disposable brushes, and follow up with more reprocessing in-services moving forward.Ess spoke with the office coordinator and provided details about the concerns; additional reprocessing in-services will be provided at a later date.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus endoscopy support specialist (ess) reported that during an onsite facility evaluation, it was found that staff was not performing the recommended reprocessing steps during scope reprocessing.The customer was not performing a leak test, has not been submerging the scope in a detergent solution with manual cleaning, and is not using an appropriate-sized basin or sink for reprocessing.The customer has not been using the recommended brushes.The customer was not using the well-ventilated cabinet recommended to store scopes after reprocessing.

Event Description

The customer confirmed there was no harm or consequence to the patient or healthcare professional reported as a result of the event.

Manufacturer Narrative

This report is being submitted to provide additional information to b5 and a correction to d9.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.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 failure to follow device reprocessing instructions could not be determined.The event can be prevented, by following the instructions for, use which state: "chapter 7 cleaning, disinfection and sterilization procedures 7.1 required reprocessing equipment preparation of the equipment: [caution]: use basins, which are at least 40 cm by 40 cm (16¿ by 16¿) in size.And deep enough to allow the endoscope to be completely immersed.Channel cleaning brush (bw-15b): the channel cleaning brush is used to brush the inside of the instrument and suction channels.Channel-opening cleaning brush (mh-507): the channel opening cleaning brush is used to brush the suction cylinder and the instrument channel port.7.4 leakage testing: after precleaning, perform leakage testing on the endoscope to ensure, that it is waterproof.7.5 manual cleaning: cleaning the external surface: 1.Fill a basin with water and low-foaming detergent solution at a temperature and concentration recommended by the manufacturer.Use a basin, which is at least 40 cm by 40 cm (16¿ by 16¿) in size.And deep enough to allow the endoscope to be completely immersed.2.Immerse the endoscope in the basin containing detergent solution".Olympus will continue to monitor field performance for this device.

Event Description

Additional information received, from the customer.Was no there a death, injury including infection in patients or health care professional? the malfunction did not impacted patient or health care professional.Other than health injury.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: 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: 16279640
• MDR Text Key: 309182482
• Report Number: 3002808148-2023-00973
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2023

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
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/02/2023; 02/02/2023
• Supplement Dates FDA Received: 02/28/2023; 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1