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

Model Number CYF-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2020

Event Type  Malfunction  

Manufacturer Narrative

Additional information is not yet received for this event. Event date is not known. Supplemental report(s) will be filed as any information becomes available. The device has been returned and a device evaluation completed for it. Manufacture date is not available. The device was returned for the issue of the bridge port coming out of the instrument cannel. The device was returned without any missing part or detached part including the biopsy port. Unable to duplicate the user's request. The user¿s complaint was not confirmed. Upon inspection and testing, incidental findings were decreased lighting from the light guide lens, which had some corrosion, and a trace of fluid invasion from the eyepiece.

Event Description

As reported for this event, during preparation for use for an unknown procedure the bridge port of the device came out of the instrument channel. There is no patient involvement and no harm reported to any patient.

• 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: 10951441
• MDR Text Key: 226702576
• Report Number: 8010047-2020-09867
• 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: USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/05/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: CYF-5
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse