MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5R

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, an endoscopy support specialist(ess) was dispatched to the user facility on september 02, 2020 to provide a repair reduction and education to the facility¿s staff.The ess reported that during an onsite customer visit the facility¿s reprocessing practices were discussed and the customer reported that leak testing is not performed as there is no leak tester onsite.Further discussion, found that the scope were stored in hangers at the end of the counter and not in a vented cabinet.The ess observed two tubes of disinfectant which are used to disinfect the insertion tube and not the scope in its entirety.The ess also, reported that the rinsing and drying of the scope post disinfection is not in accordance with manufacturer¿s recommendation.The device was not returned to the service center for evaluation.A review of the instrument history was performed and found no service/repair record since the date of purchase on may 13, 2014.

Event Description

The service center was informed that the user facility is improperly reprocessing two of its cystoscopes.The scopes were found to have multiple broken fibers and stains on the lens.There was no patient infection reported.This is 1 of 2 reports.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The user facility was contacted to determine if they required any additional support from olympus.The contact at the user facility responded that they were fine and that their processes are being changed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause of the reported issues is likely human error and failure to follow the instructions for use (ifu): "after pre cleaning, perform leakage testing on the endoscope to ensure that it is waterproof.".

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.As part of our investigation, an endoscopy support specialist (ess) offered the customer a reprocessing in-service training to address reprocessing deviations noted during the facility¿ repair reduction visit.The ess reported that the customer has declined support at this time.

Manufacturer Narrative

This supplemental report is being submitted to correct the february 15, 2021 aware date reported in the follow up #2 caused by a data entry error.The correct aware date for the new information is january 15, 2021.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10590093
• MDR Text Key: 224665439
• Report Number: 8010047-2020-06893
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170328817
• UDI-Public: 04953170328817
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2021

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-5R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 01/15/2021; 02/15/2021; 02/04/2021
• Supplement Dates FDA Received: 01/26/2021; 01/31/2021; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1