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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE STANDARD DEFLECTION SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE

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BOSTON SCIENTIFIC CORPORATION LITHOVUE STANDARD DEFLECTION SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE Back to Search Results
Catalog Number M006 791350 0
Device Problems Defective Device (2588); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2019
Event Type  malfunction  
Event Description
Lithovue disposable flexible ureteroscope malfunctioned during procedure (flickered on and off when deflected and then light went out altogether). Second one obtained. Device will be given to surgical materials manager to return to vendor for credit. No patient harm.
 
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Brand NameLITHOVUE STANDARD DEFLECTION
Type of DeviceSINGLE USE DIGITAL FLEXIBLE URETEROSCOPE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8292383
MDR Text Key134587793
Report Number8292383
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 01/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM006 791350 0
Device Lot Number23050074
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2019
Event Location Hospital
Date Report to Manufacturer01/31/2019
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

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