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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2020
Event Type  Malfunction  
Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation. Processing manager states that the device was brought to their facility in november of 2019. An olympus endoscopy support specialist (ess) performed a scope reprocessing and infection control in-service for facility. During the in-service the facility manager states that the scope has not been leak tested since brought to their facility in november of 2019. The ess covered infection control information referenced in the user manual and reprocessing manual. Including: "after precleaning, perform a leakage test on the endoscope to ensure that it is waterproof by using the leakage tester mb-155 or wa23070a. " after reviewing reprocessing steps processing manager at facility confirmed scope will be leak tested after each use moving forward. This report will be updated accordingly if additional and significant information is received at a later time.

 
Event Description

The user facility requested quarterly training and in-service. No adverse event reported in association with this report.

 
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Brand NameVIDEOSCOPE "CYF-V2", EUROPEAN VERSION
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 Key10169862
MDR Text Key198680116
Report Number8010047-2020-03457
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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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