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 11/13/2020

Event Type  Malfunction  

Manufacturer Narrative

This device was not returned to olympus for evaluation, but the instrument history has been reviewed and it showed that the device was purchased on (b)(6) 2014 and it was last returned to olympus for service (b)(6) 2019. The endoscopy support specialist (ess) performed cyf-5r reprocessing in-service under the direction of the office administrator. The ess emphasized the importance of the reprocessing steps according to the reprocessing manual. Ess also worked with the staff to identify equipment needs for the correct reprocessing and provided them to the urology territory manager. Additionally the ess educated the staff on the correct reprocessing steps. Finally, the ess provided follow up documentation in an email including an on-track, wall chart and reprocessing manuals for all of their equipment. This event occurred during an in-service, and therefore had no patient involvement. A supplemental report will be provided should additional information be provided.

Event Description

As reported, during a scheduled cyf-5 reprocessing in-service it was determined that the user facility was utilizing insufficient or incorrect reprocessing scope. Reportedly, during the in-service it was discovered that the user facility was not performing leak tests on their equipment and had no leak tester available to perform the activity. Additionally, they were using a 'tube' system to perform their reprocessing. In the tube system only the insertion tube is placed in detergent or disinfectant and subsequently is placed in sterile water for storage until the scope is ready for use. Meaning, the equipment is only soaked, not properly cleaned. Furthermore, the user facility had no brushes or process to clean the instrument channel. This scheduled in-service provided corrective information on how to properly care for this olympus device.

• 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: 10934701
• MDR Text Key: 219162634
• Report Number: 8010047-2020-09733
• 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,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/02/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device MODEL Number: CYF-5R
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/25/2020
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse