MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", UK VERSION; FLEXIBLE VIDEO CYSTONEPHROSCOPE

Model Number CYF-V2

Device Problem Device Reprocessing Problem (1091)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

The olympus endoscopy support specialist (ess) became aware during an in-service appointment at the user facility in support of newly purchased equipment, that the endoscope reprocessing method was not being performed correctly, and that a tube that only immerses the insertion tube in high level disinfectant was being used, and the user was not immersing the entire scope in water for leak testing, detergent for manual cleaning, water for rinsing, or high-level disinfectant.The user wipes the insertion tube down with a lint free cloth with detergent, then inserts the insertion tube in high level disinfectant and brushes the channels.There was no patient injury or infection reported due to the event.Additional details were requested regarding the reported event; however, no further information was provided.

Manufacturer Narrative

The subject device was not returned to olympus for evaluation as there was no report of non-conformity of the device.During the onsite visit, the ess advised the customer on the recommended reprocessing steps per the olympus instructions for use and recommended additional in-service for reprocessing be scheduled for staff.The investigation is ongoing; therefore, a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

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.Approximately less than 1 year has passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, the cause of the phenomenon could not be determined.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): chapter 7 cleaning, disinfection, and sterilization procedures.7.1 required reprocessing equipment.[warning].¿ use basins that are at least 40 cm by 40 cm (16¿ by 16¿) in size and deep enough to completely immerse the endoscope.¿ incomplete immersion of the endoscope may reduce effectiveness of reprocessing.Olympus will continue to monitor the field performance of this device.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: FLEXIBLE VIDEO CYSTONEPHROSCOPE
• 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: 15405610
• MDR Text Key: 300094308
• Report Number: 8010047-2022-12140
• Device Sequence Number: 1
• Product Code: NWB
• 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,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• 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