• 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-V
Device Problems Hole In Material (1293); Material Perforation (2205); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2016
Event Type  malfunction  
Manufacturer Narrative
This device referenced in this report has been returned to olympus and the evaluation is ongoing. The manufacturing record of the device was reviewed with no irregularity found. If additional information becomes available at a later time, this report will be supplemented.
 
Event Description
The subject device was used for an ureterorenoscopy to crush stones. During the procedure, the wire stuck out of the bending rubber. The user facility completed the procedure using the subject device. According to the surgeon, at the beginning of the procedure, there was no damage to the subject device recognized. There was no serious patient injury reported, but further information was not provided.
 
Manufacturer Narrative
This report is submitted to report the evaluation result of the subject device. The evaluation found that a part of the braid lines protruded from the bending section. The bending section of the subject device has a braid under the bending rubber; the braid is a tube-like part of mesh which is woven of multiple braid lines. Some of the braid lines running to only top-right direction from the distal end of the subject device had a buckling and fracture, while the braid line running to down-right direction had no buckling and fracture. The exact cause could not be conclusively determined, but from the damage of the braid lines, it was likely caused by fracture of the braid lines which was caused by an excessive torque applied from a single direction to the bending tube. For example, during an approach to lesion in the renal calyx or whatever, if the control section is forcibly rotated with angulated, the bending tube is expected to be subject to an excessive torque.
 
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 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
6425177
MDR Report Key5681038
MDR Text Key45960656
Report Number8010047-2016-00671
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K#: K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Device Catalogue NumberURF-V
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-