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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The scope was returned to the service center for evaluation. A visual inspection of the returned scope found pieces of the bending section cover missing. Due to the missing piece of bending section no leak test could be performed. The bending section glue was noted to be cracked. There were minor dents noted on the scope¿s insertion tube. The most likely cause of the reported event can be attributed to mishandling. The cyf-v2 instruction manual states ¿do not squeeze the bending section forcefully. The covering of the bending section may stretch or break leading to fluid invasion into the endoscope. ¿ the manual also, states how to prevent damage to the insertion tube. Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force. The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation. It could also cause parts of the endoscope to fall off inside the patient. ¿.

 
Event Description

The service was informed that the scope was noted to be damaged at the distal tip. There was no patient involvement reported.

 
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Brand NameVISERA CYSTO-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 Key10016310
MDR Text Key200816542
Report Number8010047-2020-02424
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 06/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/27/2013
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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