MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE, "CYF-5", UK VERSION CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Unclear Information (4052)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  Malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation. No additional information has been obtained from the customer. No other issues or injuries have been reported. If any additional information is obtained a follow up report will be filed.

Event Description

The user facility reported a damaged fiberscope and that they also needed to know how to clean the scope. No patient involvement was reported. No additional information has been obtained.

• Brand Name: FIBERSCOPE, "CYF-5", UK VERSION
• 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: 10361742
• MDR Text Key: 202609061
• Report Number: 8010047-2020-05254
• 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
• Report Date: 10/01/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 08/04/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-5
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/07/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse