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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 Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/04/2019
Event Type  Injury  
Event Description

The manufacturer became aware that during procedure, the doctor inserted the endoscope into the patient's urethra and lost view. The doctor went to withdraw the endoscope but the endoscope got stuck and became kinked and folded over. The doctor was eventually able to withdraw and straighten the endoscope. As a result, the patient suffered bleeding, urethra trauma and the patient had to be cauterized.

 
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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
MDR Report Key9146213
MDR Text Key162870413
Report Number2951238-2019-01133
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/04/2019,10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/04/2019
Event Location Hospital
Date Report TO Manufacturer09/04/2019
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

Patient TREATMENT DATA
Date Received: 10/02/2019 Patient Sequence Number: 1
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