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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-5
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 08/14/2020
Event Type  Injury  
Manufacturer Narrative

The device was returned to olympus and evaluation is pending. If additional information becomes available at a later time, this report will be supplemented. This event has been reported by the importer on mdr# 2951238-2020-00493.

 
Event Description

Patient 2 of 4. It was reported the patient experienced an infection following a procedure that involved the device. Although requested, additional information has not been provided at this time.

 
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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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10559929
MDR Text Key207732865
Report Number8010047-2020-06700
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated By Manufacturer? No
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: 09/21/2020 Patient Sequence Number: 1
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