• 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. URETERO-RENO 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. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V3
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
Olympus medical systems corp. (omsc) will start evaluating the subject device. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user that after ethylene oxide gas sterilization, the black foreign material came out of the instrument channel of the subject device. Other detailed information was not provided. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. The subject device and the sterilization tray were returned to olympus medical systems corp. (omsc) for evaluation. Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. Omsc confirmed the subject device as following. There was no foreign material in the subject device. The instrument channel of the subject device failed a leakage test. The black foreign material was attached to the sterilization tray. The black foreign material was composed of carbon and sodium chloride based on a component analysis. The exact cause of the reported phenomenon could not be conclusively determined. Omsc surmised that the reported phenomenon occurred due to the following causes. The instrument channel of the subject device was broken since the user inserted or withdrawn the endo-therapy accessories into the instrument channel with the distal end open. The foreign material might be the carbon which was used for lubricant and came from the damaged part of the instrument channel. Also, sodium chloride could come from solution such as saline.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO 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 Key11722662
MDR Text Key256772345
Report Number8010047-2021-05376
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-