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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

The subject device has not been returned to omsc for evaluation. Local service division of olympus has contacted the user facility several times, but has not obtained any additional information. The exact cause could not be determined at present, if significant additional information is received, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that the user facility suspected of infection in several patients after using the subject device in procedures. There was no report of patient outcome associated with this report. The user facility reported that the subject device had been reprocessed using an olympus automated endoscope reprocessor model mini etd-2 (not available in the usa) and they had not performed manual cleaning of the instrument channel before disinfecting with mini etd-2.

 
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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
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6878310
MDR Text Key86701061
Report Number8010047-2017-01352
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberPK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberCYF-5A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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