• 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 FIBERSCOPE

  • 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 FIBERSCOPE Back to Search Results
Model Number URF-P6
Device Problem Optical Problem (3001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2017
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has been returned to olympus medical systems corp., then, we confirmed the complaint phenomenon.And, it was confirmed that there were many image guide breakage, they were concentrated in the bending section.It was confirmed that there was no misalignment of inner components inside the bending section.There was no damage with the bending section.There was no problem with the movement of the internal objects.The manufacture record of the subject device was reviewed with no irregularity.The exact cause of the event could not be determined at this moment.
 
Event Description
The black dots in the field of view suddenly increased during use by the tul (transurethral ureterolithotripsy) and became unusable.The user facility had replaced it with another device, and the procedure was completed.There was no report of patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
URETERO-RENO FIBERSCOPE
Type of Device
URETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6739219
MDR Text Key80929129
Report Number8010047-2017-00930
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberURF-P6
Initial Date Manufacturer Received 06/28/2017
Initial Date FDA Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-