• 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-P7
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed that during reprocessing of the subject device, the user facility noticed that there was a hole in the rubber of the bending section and the bending section did not bend.There was no report of patient injury associated with the event.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).On march 9th, 2020, (b)(4) evaluated the subject device and confirmed that there was a hole in the rubber of the bending section and the bending section did not bend in the down direction.In addition, it was confirmed that a metal was found to be sticking out from the bending section.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
 
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
MDR Report Key9919624
MDR Text Key208347251
Report Number8010047-2020-01964
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/24/2020
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 Health Professional
Device Model NumberURF-P7
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/09/2020
Initial Date FDA Received04/03/2020
Supplement Dates Manufacturer Received05/29/2020
Supplement Dates FDA Received06/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-