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

Model Number CYF-VHR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this case was not returned to olympus for physical evaluation. An olympus field representative compared the complaint scope to another manufacturer's scope in the field and noted that the insertion tube outer diameter of the olympus scope is 0. 5mm bigger than other manufacturer's cystoscope and the distal end of the olympus scope is smaller (8. 1fr) compared to the other manufacturer's scope (10. 9fr). Additional information regarding the patients/event is being pursued. At the time additional relevant details becomes available and/or at completion of the investigation, this report will be updated accordingly.

Event Description

It is reported that two physicians have mentioned that the olympus cysto-nephro videoscope is bigger than another manufacturer's scope making it more traumatic to navigate in patients with urethral stenosis, and this lead to increased bleeding and tearing in a couple of cases. No additional information is available at this time. There was no report of any device malfunction.

• 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: 10747664
• MDR Text Key: 213428451
• Report Number: 8010047-2020-08222
• 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
• Report Date: 10/28/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/28/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-VHR
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/09/2020
• 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

Patient TREATMENT DATA

Date Received: 10/28/2020 Patient Sequence Number: 1