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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-VH
Device Problem Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus and evaluated. The reported problem was confirmed. When the scope was tested, leaking was noted due to a cut in the light guide tube. In addition, the bending section c-body was found detached. Based on similar reported complaints, the most likely cause of the reported event can be attributed to user handling or technique. The device instructions for use contains the following warning statements: warning: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector. Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. Warning: do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector. The endoscope may be damaged, and water leaks and/or breakage of internal parts like the image sensor cable can result.

 
Event Description

A user facility reported their olympus cysto-nephro videoscope failed the leak test during reprocessing. There was no patient injury or harm associated with the reported problem.

 
Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer's investigation and device history record (dhr) review. A dhr review was performed. There were no abnormalities in manufacturing found and it was verified the device was manufactured in accordance with documented specifications and procedures. The legal manufacturer was unable to determine a conclusive root cause for the reported problem. However, the legal manufacturer's investigation confirmed that the likely cause of the leak was due to user handling. The detached distal end, identified upon device evaluation, was determined by the legal manufacturer likely associated with adhesion strength. An investigation is ongoing related to the root cause of the finding of "detached distal tip. ".

 
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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 Key10224269
MDR Text Key224633070
Report Number8010047-2020-03836
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2020
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 Reuse

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