• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K UHD LCD MONITOR

  • 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
 

SHIRAKAWA OLYMPUS CO., LTD. 4K UHD LCD MONITOR Back to Search Results
Model Number OEV321UH
Device Problems No Display/Image (1183); Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2023
Event Type  malfunction  
Event Description
Customer reported that they had a patient on the table and the slave monitor was not working as it should be.According to the reporter, this caused a delay of around 10 minutes whilst they were on the phone with the customer care.In a follow communication, it was confirmed that the issue was first noticed when the patient was under ga (asleep) while having the procedure.According to the report customer had to wheel the patient to another room which had both monitors working.The issue occurred during a diagnostic colonoscopy procedure.According to the report, there was delay of about fifteen (15) minutes in the procedure.There was no patient harm or injury reported.The intended procedure was completed using a similar device.No harm was reported, no user injury reported.
 
Manufacturer Narrative
The subject device was not returned for evaluation.In a follow up communication with olympus territory manager (tm) who visited the customer site, it was reported the issue with the customers monitor was resolved.The tm reported that the issue was not with the monitor.The customer turned off the endo-aid (an application for computer-aided detection powered by ai ) which in turn cut the image from the cv-1500 to oev unit.According to the tm, it was determined to be human factors and not the equipment, stated that the team have been trained previously on not turning the endo-aid off.Investigation is ongoing.This report will be supplemented accordingly following investigation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the monitor issue was the user not turning the power on.The monitor issue might have been prevented by following the description in the instruction manual.The product has a function to assist with detecting mucosal abnormalities.Olympus will continue to monitor field performance for this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4K UHD LCD MONITOR
Type of Device
MONITOR
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16588863
MDR Text Key312216145
Report Number3002808148-2023-02813
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier04953170418723
UDI-Public04953170418723
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K220069
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOEV321UH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/21/2023
Initial Date FDA Received03/22/2023
Supplement Dates Manufacturer Received04/06/2023
Supplement Dates FDA Received04/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CV-1500 VIDEO SYSTEM
-
-