• 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 Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The referenced scope was returned to the service for evaluation. The reported broken fibers was confirmed as 20+ black dots were found on the image; indicating excessive broken image guide fibers. A visual inspection of the scope found the bending section skeleton tab is protruding out from the bending section cover near the insertion tube area. The bending section cover was removed and the bending section skeleton is fully broken, separated and cracked with sharp edges on the surface of the breaking point. In addition, there is passage restriction in the instrument channel. The scope failed the leak test from the bending section and from the instrument channel. A review of the instrument history indicated the scope was previously repaired on april 16, 2019. Based on the evaluation the most probable cause of the broken image fibers and the broken bending section skeleton is attributed to (unintended) excessive stress and force applied to the bending section area. Insufficient information was provided by the user facility. Multiple follow ups were made to obtain additional information from the user facility but with no results. However, if additional information becomes available, this report will be supplemented accordingly. The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury. ¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient. If the up/down angulation control lever does not move. If the angulation control mechanism is not functioning properly. Visually inspect the bending section for no metallic parts protruding from the bending section. Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight. Visually inspect the bending section for abnormal bending shape, or other irregularities. Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation. ".
 
Event Description
The manufacturer was informed that the image of the scope has broken fibers. There was no serious injury or death reported.
 
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 Key8837142
MDR Text Key216104052
Report Number8010047-2019-02726
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 07/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-