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

Model Number CYF-V2

Device Problem Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/19/2020

Event Type  Malfunction  

Manufacturer Narrative

The device referenced in this report has been received by olympus, but has not yet been fully evaluated. The definitive cause of the customer's experience can not be determined at this time. This report will be updated upon completion of the investigation and if any relevant additional information is available.

Event Description

It is reported during a diagnostic cystoscopy using topical anesthetic (lidocaine gel) and a visera cysto-nephro videoscope, at the end of the procedure, the angulation on the scope became locked and would not disengage/straighten out and was stuck in the patient's urethra. The scope retroflexed at 180 degrees. There was urethral dilation that caused minor bleeding/mucosal tears requiring no treatment. There was no delay in the procedure and the planned procedure was completed using the complaint device. No additional consequences to the patient were reported. The scope was inspected prior to use and no damage or abnormalities were noted.

• Brand Name: VISERA 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: 10825092
• MDR Text Key: 224686833
• Report Number: 8010047-2020-08794
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL,USER FACI

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/11/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-V2
• 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: 12/16/2020
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 06/06/2011
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse