• 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 VIDEOSCOPE

  • 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 VIDEOSCOPE Back to Search Results
Model Number URF-V2R
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was return to olympus for evaluation. The device was visually inspected and found a portion of the bending section skeleton protruding out from the bending section cover near the insertion tube side. The bending section damage is approximately 70mm from the distal end side, which is causing a leak on the bending section cover. The bending section cover was removed in order to reveal the extent of the damage to the bending section. Upon removal of the bending section cover, it was confirmed that the bending section skeleton is fully separated producing sharp edges near the insertion tube side. The condition of the bending section support pins and found, six out of twelve pins receding into the channel and lifting. The instruction manual states the following: ¿do not twist or bend the bending section with your hands. Equipment damage may result¿. The instructions for safe use manual also indicates that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment. This file will be updated if additional information is received.
 
Event Description
The device was returned to olympus for evaluation and service after an air/water leakage and fluid invasion where it was reported that the scope had a visible break in the insulation. No patient involvement was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
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 Key10188783
MDR Text Key198860755
Report Number8010047-2020-03605
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-