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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V3R
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/12/2021
Event Type  Injury  
Event Description
It is reported during an unspecified procedure using an uretero-reno videoscope, the scope became stuck inside the patient. The physician changed to an open approach to finish the procedure and remove the entrapped device. In the process of removing the entrapped device, part of the patient's ureter was removed. Efforts were made to request additional details regarding the patient and event. The customer responded "we have reported this event through medsun. Information regarding the event will be shared with you through that process".
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key11604790
MDR Text Key243463108
Report Number2951238-2021-00311
Device Sequence Number1
Product Code FGB
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,Followup
Report Date 03/15/2021,05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/15/2021
Event Location No Information
Date Report to Manufacturer03/15/2021
Date Manufacturer Received05/06/2021
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

Patient Treatment Data
Date Received: 04/01/2021 Patient Sequence Number: 1
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