• 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 Material Protrusion/Extrusion (2979)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The urf-v2 video scope, serial number (b)(4) was returned to manufacturer for evaluation due to failing leak test and metal protrusion. The user¿s complaint related to the scope damage was confirmed. The manufacturer performed a visual inspection on the device and found the bending section skeleton protruding out from the bending section cover. The bending section damage was approximately 70 mm from the distal end side, which was also 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 was fully separated producing sharp edges near the insertion tube side. The manufacturer also checked the condition of the bending section support pins, which were not lifted or receding. 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 is a newer type ns unit (post counter measure) that was verified by the positioning of the bending section tab; in conjunction with the value (2) of the third digit of the serial number, according to the service center repair work aid. Based on the evaluation, the most probable cause of the bending section skeleton breaking was due to excessive force and/or stress from mishandling.
 
Event Description
The user facility reported that during reprocessing the endoscope failed the leak test multiple times. The sheath was bent approximately three (3) inches from the distal tip. There was also report of metal protrusion. There was no patient involvement 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 Key9104177
MDR Text Key213882770
Report Number8010047-2019-03345
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
Report Date 09/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2019
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 Manufacturer08/26/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2019
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

-
-