• 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 Break (1069)
Patient Problem Unspecified Infection (1930)
Event Date 07/15/2019
Event Type  Injury  
Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to (b)(4) for evaluation and repair. The evaluation is in progress. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that three patients were infected with pseudomonas after cystoscopy using the subject device. In addition, it was reported that one of three patients died. However, the relationship between the death and subject device and the infection is currently unknown. The two patients¿ condition other than the expired patient is currently unknown. The user facility returned the subject device to olympus for repair because the subject device did not pass a leakage test. The user facility had cleaned the subject device using a non-olympus single use cleaning brush (mi-cb-sweep-port, cantel) and reprocessed the subject device using a non-olympus automated endoscope reprocessor (medivators rapidaer, cantel), using a non-olympus disinfectant (rapicide part a and rapicide part b, cantel). Omsc is submitting three medical device reports according to the number of the infected patients. This is two of three reports.

 
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 Key8854169
MDR Text Key153068302
Report Number8010047-2019-02806
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/02/2019 Patient Sequence Number: 1
-
-