• 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. VIDEOSCOPE "CYF-V2", UK VERSION 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. VIDEOSCOPE "CYF-V2", UK VERSION CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. During the evaluation the reported issue was confirmed. The device failed the leak test due to bending cover damage. A deep dent was found on the bending section. No other damages were found. If additional information is obtained a supplemental report will be filed.

 
Event Description

The user facility reported that the videoscope had bending manipulation and insertion tube defects. That the rubber was hanging off the scope. No patient involvement was reported. No additional information has been obtained.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIDEOSCOPE "CYF-V2", UK VERSION
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 Key10361641
MDR Text Key201589939
Report Number8010047-2020-05252
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 08/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/08/2020
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

-
-