• 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 Display Difficult to Read (1181)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus (b)(4) before the subject device was returned to olympus medical systems corp. (omsc). According to the investigation by ofr, it was found that two cable supports in the bending section were peeled off. The subject device has been returned to omsc for evaluation now. However, the evaluation is in progress at this time. The exact cause of the reported event could not be conclusively determined at this time. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Event Description
At an unspecified timing, more than 20 black dots were displayed on the endoscopic image. There was no report of the patient¿s injury regarding this event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. Olympus medical systems corp. (omsc) investigated the subject device and concluded as the following. About the black dots displayed on the endoscopic image: omsc considered that the stress was applied to the image guide bundle and the image guide was broken. About the cause of cable support peel-off: during the procedure to access the inferior calyx of kidney, the angle operation was forcibly performed with the distal end fixed inside the kidney. As a result, the cable support was stressed and peeled off from the bending section. The device history record indicates that the subject device has been shipped in conformity to the specifications. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key9222532
MDR Text Key194446938
Report Number8010047-2019-03666
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-