• 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-V2
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was sent to the service center for evaluation. A visual inspection was performed on the received device and noted the bending section skeleton tab was protruding from the bending section cover. The scope failed the leak test due to the protruding skeleton tab. The bending section cover was removed and found the bending section skeleton tab was fully broken/detached and causing exposure on the internal elements at the insertion tube area. Additionally, there was no significant evidence of sharp areas noted with the broken/detached skeleton. In the instruction manual it states that ¿do not twist or bend the bending section with your hands. Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damage. ¿.
 
Event Description
The service center was informed that the scope¿s distal tip was broken. The breakage was noted by the technician during reprocessing. It was reported that the scope was then sent to user facility¿s materials management department, where a second inspection was performed and confirmed the scope breakage before sending it to the manufacturer.
 
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 Key8837283
MDR Text Key152533872
Report Number8010047-2019-02727
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 user facility
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-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
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

-
-