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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM Back to Search Results
Model Number CYF-V2
Device Problem Peeled/Delaminated (1454)
Patient Problem Insufficient Information (4580)
Event Date 01/07/2021
Event Type  Malfunction  
Event Description

Patient underwent elective nephrolithotripsy. When the doctor removed the cysto-nephroscope from the patient the black protective covering on the flexible part of the scope had "peeled" away from the scope, exposing the inner material of the scope. The black protective covering had been intact when first inserted into the patient. No pieces of this black covering were noted to be left inside the patient. Manufacturer response for flexible digital cysto videoscope, olympus (per site reporter). Information not available at the time of this report.

 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2400 ringwood ave
san jose CA 95131
MDR Report Key11228737
MDR Text Key228693081
Report Number11228737
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/20/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Device Catalogue NumberCYF-V2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/20/2021
Device Age3 yr
Event Location Hospital
Date Report TO Manufacturer01/26/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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