• 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-V
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2015
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus for evaluation. The reported phenomenon was reproduced. The evaluation revealed that there were perforation in the a-rubber, burned bending tube, snapped angulation wire, and perforation in the channel in up-side of the tube at 18 mm and 30 mm from the distal end. The interior of the control body was checked and the angulation wire was found intact. Based on the user facility's comment and the above evaluation result, the subject phenomenon is considered to be attributable to the snapped up-angulation wire due to the inadvertently irradiated laser. The manufacturing record of the subject device was reviewed with no abnormality possibly related to the subject phenomenon.
 
Event Description
Olympus was informed that the user became aware that angulation was unable when the user inserted the subject device into the ureter for f-tul (flexible transurethral lithotomy). The treatment was aborted due to the availability of a spare device, and the procedure was concluded by placing a stent. The user facility commented that the possible cause might be irradiating laser inadvertently while the laser device was still in the scope. It is unclear when the laser was inadvertently irradiated. There was no patient injury reported.
 
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 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
6425177
MDR Report Key5359623
MDR Text Key35622445
Report Number8010047-2016-00091
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K#:K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 01/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Device Catalogue NumberURF-V
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-