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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number OLYMPUS URF-V2R
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2020
Event Type  malfunction  
Event Description
The flexible ureteral scope broke inside the ureter while doctor was manipulating it. This made it extremely hard to remove, and also increasing the risk of ureteral tear. The removal did not damage the ureter.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2400 ringwood ave
san jose CA 95131
MDR Report Key10157443
MDR Text Key195243146
Report Number10157443
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOLYMPUS URF-V2R
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/02/2020
Event Location Hospital
Date Report to Manufacturer06/16/2020
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

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