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 olympus 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 on site 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 on site. 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.

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 2 of 2 reports.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10590003
• MDR Text Key: 214768470
• Report Number: 8010047-2020-06892
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/25/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/25/2020
• 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
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse