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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 Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 11/06/2020
Event Type  Malfunction  
Manufacturer Narrative

Additional information is not yet received for this event. Event date is not known. Supplemental report(s) will be filed as any information becomes available. The device has been returned and a device evaluation completed for it. Manufacture date is not available. The device was returned for the issue of the bridge port coming out of the instrument cannel. The device was returned without any missing part or detached part including the biopsy port. Unable to duplicate the user's request. The user¿s complaint was not confirmed. Upon inspection and testing, incidental findings were decreased lighting from the light guide lens, which had some corrosion, and a trace of fluid invasion from the eyepiece.

 
Event Description

As reported for this event, during preparation for use for an unknown procedure the bridge port of the device came out of the instrument channel. There is no patient involvement and no harm reported to any patient.

 
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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 Key10951441
MDR Text Key226702576
Report Number8010047-2020-09867
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,Followup,Followup
Report Date 01/21/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2017
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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