• 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-V3
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. The repair center found the black covering of the bending section was missing and the cable support of the curved pipe was disconnected. The device was repaired and returned to the customer. Based on the investigation, it is presumed the black covering of the bending section was completely removed by the user before sending the unit to olympus. Regarding the cable support, the adhesive that secured the cable support of the curved pipe was damaged and had come off. It is presumed that the user's scope handling was not appropriate. The ifu describes the method for detecting these malfunctions: "3. 3 inspection of the endoscope: inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, insulating objects, or other irregularities. " as a method of preventing such an event, the ifu describes an operation method for preventing damage to the curved pipe. According to this ifu, damage to curved pipes can be reduced. However, it is presumed that the curved pipe was damaged because it deviated from this content this time. A review of the device history record found no deviations that could have caused or contributed to the reported issue. This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
 
Event Description
The customer contacted olympus to report the laser fiber got caught when it passed through. The device malfunction was identified during a uteroscopy procedure. The procedure was completed with another scope, serial number unknown, and there was no delay. There was no patient injury or harm related to this event. The device was inspected prior to use and no abnormalities were found.
 
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 Key11039134
MDR Text Key222406782
Report Number8010047-2020-10675
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403385
UDI-Public04953170403385
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-