• 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. OES 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. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to the service center for evaluation. The customer¿s complaint of a ¿loose port¿ was confirmed. The scope was received with a missing biopsy port, there was a deep scratch on the insertion tube. The most likely cause of the reported event is mishandling. The instruction manual provides the statement below in an effort to mitigate damage to the scope. Important information- please read before use. "do not strike the distal end of the insertion tube or allow it to strike other objects. The objective lens surface at the distal end is particularly fragile, and visual abnormalities may result. ¿.

 
Event Description

The service center was informed that during reprocessing, the scope¿s instrument channel port was noted to be loose. The scope¿s channel port valve connector came off. There was no patient involvement.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOES CYSTONEPHROFIBERSCOPE
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 Key10998129
MDR Text Key221294813
Report Number8010047-2020-10260
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/11/2020
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

-
-