MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHR

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated. The user reported problem of "distal sheath separating, distal tip damaged" was confirmed. The distal end cover was found detached. A definitive root cause for the reported problem could not be determined.

Event Description

Olympus was informed that a user facility's scope distal end sheath was separating and damaged. The problem reportedly occurred during reprocessing and was found during reprocessing. It was reported there was no patient involvement associated with the problem.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of a device history record (dhr) review. The dhr was reviewed for the device involved. As a result of reviewing the dhr, it was confirmed that there were no abnormalities, special adoptions, or variations in the manufacturing process.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• 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: 9988878
• MDR Text Key: 222564043
• Report Number: 8010047-2020-02334
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• 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,Followup
• Report Date: 06/05/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/22/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VHR
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/05/2020
• 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