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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOR GU OLYMPUS URETEROSCOPE URF P6R-2402235 URETEROSCOPE AND ACCESSORIES, FLEXIBLE / RIGID

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MOR GU OLYMPUS URETEROSCOPE URF P6R-2402235 URETEROSCOPE AND ACCESSORIES, FLEXIBLE / RIGID Back to Search Results
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/28/2018
Event Type  Injury  
Event Description
Flexible ureteroscope lodged in mid ureter, delayed removal. Olympus.
 
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Brand NameMOR GU OLYMPUS URETEROSCOPE URF P6R-2402235
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
MDR Report Key8197328
MDR Text Key131839799
Report NumberMW5082601
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 12/24/2018 Patient Sequence Number: 1
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