• 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. EVIS CYSTO VIDEOSCOPE 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. EVIS CYSTO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-240
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus repair center for evaluation. The evaluation of the device confirmed the following: instrument channel port had an additional attached fitting maj-891. The maj-891 is attached to the device before a procedure, and removed during reprocess. When the maj-891 was removed, the instrument channel port came away from the device. The manufacturing history (dhr) confirmed no irregularity. Omsc guessed that the reported event was caused by the excessive stress occurred when putting on, and taking off the maj-891. There is possibility that the excessive stress was caused by user handling. If additional information becomes available, this report will be supplemented.

 
Event Description

Instrument channel port of the device was loose. There was no report of patient injury associated with this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVIS CYSTO 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 Key10571071
MDR Text Key208829970
Report Number8010047-2020-06752
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-240
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/06/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-