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

Model Number CYF-VH

Device Problem Fluid Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation. The user¿s complaint was confirmed. The device was visually inspected and found the video cable leak. There was glue cracked on bending section cover (a-rubber). The distal end of the bending section was detached. The listed parts were replaced. The device was returned to full functionality and returned to the user facility. This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The user facility reported that the device failed a manual leak test. There was no patient involvement. No additional information was provided.

• 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: 10551677
• MDR Text Key: 211095331
• Report Number: 8010047-2020-06646
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/17/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VH
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/26/2016
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse