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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 Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

There is no additional information available for this event as yet. Event date is not known. Supplemental report(s) will be filed as any information becomes available. The device has been returned but the actual device evaluation is not completed. An evaluation from historical data is available and included here. The device history review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing. The device shipping was under normal conditions. The device cap was left open during reprocessing is the likely cause of the issue. Instructions for use include statement: for eog sterilization: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization. If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism. ) for ethylene oxide gas sterilization: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization. If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism. Device evaluation is not yet completed.

 
Event Description

As reported for this event, during reprocessing the rubber at the distal end peeled off. The cap had been left open. There is no patient involvement.

 
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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 Key10488259
MDR Text Key224635716
Report Number8010047-2020-06160
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 OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2020
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 Manufacturer09/03/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/23/2016
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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