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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-VHR
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Due diligence for additional information was executed. Event date is not known. Supplemental report(s) will be filed as any information becomes available. The device has been returned and a device evaluation completed for it. The device history review confirmed that there were no abnormalities, special adoption, or variations in manufacturing. Device was shipped under normal conditions. Upon inspection, it was observed that the bending section body of the device was detached. In addition, there was a cut on the insulation of the bending section and a crack on the glue. There was leaking observed and the user¿s complaint was confirmed. Other incidental observations were minor scratches on light guide tube and the distal end plastic cover, as well as continuous white paint peeling on the insertion tube. Root cause for the issue is under investigation especially with respect to the adhesive strength of the device. The instructions for use caution: ¿do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leaks. " this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

 
Event Description

As reported for this event, during reprocessing the device did not pass the leak test. There was no harm or adverse impact to any patient.

 
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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 Key10543910
MDR Text Key212592778
Report Number8010047-2020-06591
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-VHR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/03/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/17/2018
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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