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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHA
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed from the facility that the bending section of the subject device was broken during reprocessing after a cystoscopy procedure. The user facility had completed the intended procedure with the subject device. The service department of olympus (b)(4) checked the subject device and found that the distal end was detached from the bending section. There was no report of patient injury associated with this event.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
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 Key10231319
MDR Text Key197852092
Report Number8010047-2020-03902
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-VHA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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