• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHR
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Date 11/16/2020
Event Type  Malfunction  
Manufacturer Narrative

This report is being submitted to provide the customer's reported experience and the investigation findings. Investigation results: the device history record (dhr) for this device was reviewed and indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. Physical evaluation of the complaint device reveals the distal end rubber is peeled off with exposed thread. The m-plug is cracked. Review of the instructions for use (ifu) shipped with the device provides the customer the following information related to this issue: important information ¿ please read before use caution: do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leaks. Conclusions: the root cause could not be identified. Based on the investigation results, the probable causes include: there is a possibility that the distal end was damaged because the adhesion strength of the distal end was weak; or the distal end may have been damaged due to age deterioration.

 
Event Description

It is reported during reprocessing of a cysto-nephro videoscope, the distal end was found to be peeling and flaking. There is no patient contact/impact related to this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-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 Key10987130
MDR Text Key227200324
Report Number8010047-2020-10193
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/30/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-