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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 Device Reprocessing Problem (1091); Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

There is no additional information available for this event yet. The event date is unknown. Supplemental report(s) will be filed as the information becomes available. The device has been returned and a device evaluation completed for it. The manufactured date is not known. The user¿s complaint of torn bending section cover is confirmed. Upon inspection, it was noted that the device bending section cover was ripped off, likely by handling during reprocessing. In addition, upon the leak test being performed, the device had a heavy leak coming from the channel. There was also a large tear on the wall of the channel which was observed when boroscoped. There was no image issue with the device. In conclusion of the evaluation, the likely cause of the issue is handling of the device during reprocessing.

 
Event Description

As reported for this event, during reprocessing, the device bending section cover was torn while holding pressure. There was mention of no image yielded. 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 Key10155006
MDR Text Key223637580
Report Number8010047-2020-03366
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,Followup
Report Date 11/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/15/2020
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 Manufacturer05/21/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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