• 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. CYSTO-NEPHRO 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
 

SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.In addition, the following non-reportable malfunction was found during device evaluation: insufficient angle.The investigation is ongoing.A supplemental report will be submitted upon the investigation's completion or if the user facility provides any additional information.
 
Event Description
The customer reported to olympus that the cysto-nephro videoscope biopsy channel port was found to be detached during maintenance.During inspection and evaluation, the biopsy channel port was dislodged due to physical stress.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during incoming inspection and evaluation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of the dislodged biopsy channel port was due to physical stress.The event can be detected/prevented by following the instructions for use which state: "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." olympus will continue to monitor field performance for this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CYSTO-NEPHRO VIDEOSCOPE
Type of Device
CYSTO-NEPHRO VIDEOSCOPE
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 Key16697188
MDR Text Key312873660
Report Number3002808148-2023-03456
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K221683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/13/2023
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 NumberCYF-VH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/07/2023
Initial Date FDA Received04/06/2023
Supplement Dates Manufacturer Received04/20/2023
Supplement Dates FDA Received05/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-