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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 Problems Break (1069); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending. If additional information becomes available this report will be supplemented accordingly.

 
Event Description

It was reported that during reprocessing the device instrument port came out. There was no patient involvement on this event. No user injury reported.

 
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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 Key11015418
MDR Text Key221859094
Report Number8010047-2020-10410
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
Report Date 12/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/16/2020
Is This An Adverse Event Report? No
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 Manufacturer11/19/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2020
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

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