• 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. FIBERSCOPE, "CYF-5", UK VERSION CYSTONEPHROFIBERSCOPE

  • 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. FIBERSCOPE, "CYF-5", UK VERSION CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for evaluation. The customer¿s complaint was confirmed as the scope¿s forceps elevator cover was found missing. There were scratches noted on the plastic cover of the scope. The image was noted to be foggy due to fluid invasion. The bending section rubber was found damage. The insertion tube was found to be dented and with surface scratches. There was 10 broken strands noted in the light guide bundle. The scope¿s eyepiece was found foggy due to fluid invasion causing corrosion.
 
Event Description
The customer reported that the scope¿s instrument channel connect comes off during reprocessing. There was no patient involvement reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBERSCOPE, "CYF-5", UK VERSION
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key11642361
MDR Text Key244684044
Report Number8010047-2021-04761
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-