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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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BOSTON SCIENTIFIC CORPORATION LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number M0067913500
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2018
Event Type  malfunction  
Event Description
Approximately one hour and fifteen minutes into use when the screen showed a light bulb with a line and went back to instruction "home" screen. A second litho vu digital flexible ureteroscope was opened and used at no additional charge to patient.
 
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Brand NameLITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key7859554
MDR Text Key119660994
Report Number7859554
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 Risk Manager
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM0067913500
Device Lot Number22371315
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2018
Event Location Hospital
Date Report to Manufacturer09/10/2018
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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