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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION LITHOVUE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 791350
Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 03/24/2017
Event Type  malfunction  
Event Description
While using a disposable lithovue (a flex ureteroscope) the picture on the screen shut off. The device did not work as intended and was replaced. Manufacturer response for ureteroscope, lithovue (per site reporter): the field rep took possession of device and will return for quality inspection.
 
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Brand NameLITHOVUE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key6479763
MDR Text Key72368702
Report Number6479763
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model Number791350
Device Lot Number20269480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/28/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer03/28/2017
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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