• 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 Problems Break (1069); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was received and evaluated at rrc (regional repair center) olympus (b)(4). During the initial inspection bending section breakage and perforation of the a-rubber were clearly identified showing a significant metal exposure. Tape was wrapped around the rubber of the distal end to seal the known leak as to perform properly the leak test. Further inspection of the device, the following findings were noted. Air leak of the a-rubber likely due to breakage of the bending section. Ig bundle breakages. Device evaluation showed the customer reported issue could be confirmed. Investigation is ongoing. This report will be supplemented accordingly following investigation.
 
Event Description
As reported, many black dots and tip leaks observed on the device. The issue found during reprocessing. There is no patient involvement associated on this reported event. No user injury reported. Device inspection found bending section breakage and perforation of the a-rubber were clearly identified showing a significant metal exposure.
 
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 Key13049235
MDR Text Key284454949
Report Number8010047-2021-16459
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
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 Manufacturer11/23/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-