MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", UK VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problems Failure to Disinfect (1175); Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event is (b)(6) 2022.The ess performed a reprocessing in-service with the staff that covered the guidelines on reprocessing the olympus scopes per the on-track form and reprocessing manual.The staff also performed a return demonstration to show they understood the process.The customer also understood that the olympus reprocessing manuals are the validated source of instructions.As the investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The endoscopy support specialist (ess) reported that during an onsite reprocessing in-service at the customer¿s site, it was noted that the scope was being improperly reprocessed.The ess observed they do not perform bedside cleaning, and they do not leak test the scope because they do not have a leak tester.It was also noted their manual cleaning consisted of brushing the scope followed by placing only the insertion tube part of the videoscope "cyf-v2" into a high-level disinfectant solution (cidex) and then wiping the handle part of the scope with alcohol.There was no reports of harm or patient injuries reported.There was no associated patient infection reported.

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 event occurred because the user facility was not handling the device in accordance with the instructions for use (ifu).Chapter 7 cleaning, disinfection, and sterilization procedures in the ifu can prevent the event: "if the endoscope is not immediately precleaned after procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Preclean the endoscope at bedside in the procedure room immediately after each procedure." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 28-dec-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13261801
• MDR Text Key: 285064421
• Report Number: 8010047-2022-01491
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• 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