• 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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on september 29, 2021, it was found that the angulation of the subject device was locked due to corrosion of the angle mechanism of the subject device. Other detailed information was not provided. There was no report of patient injury associated with the event. This device is an olympus asset.
 
Manufacturer Narrative
Olympus medical systems corp. (omsc) could not investigate the subject device, because the subject device was not returned to omsc. 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. Since the subject device was not returned to omsc, the exact cause was unknown. Olympus service operation repair center (sorc) found that there was the air leak of the subject device. Omsc surmised that the reported phenomenon occurred since the angle mechanism of the subject device was corroded due to the air leak of the subject device.
 
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
MDR Report Key12671116
MDR Text Key281427874
Report Number8010047-2021-13489
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No

-
-