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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE URETEROSCOPE AND ACCESSORIES

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BOSTON SCIENTIFIC CORPORATION LITHOVUE URETEROSCOPE AND ACCESSORIES Back to Search Results
Model Number M0067913500
Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  malfunction  
Event Description
The device turned off mid procedure. Troubleshooting included turning device off and on without success. It just displayed 000 on screen. They also tried to unplug the device and plug it back in.
 
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Brand NameLITHOVUE
Type of DeviceURETEROSCOPE AND ACCESSORIES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key8635740
MDR Text Key145921947
Report Number8635740
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 Other Health Care Professional
Type of Report Initial
Report Date 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0067913500
Device Lot Number23449602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/13/2019
Event Location No Information
Date Report to Manufacturer05/23/2019
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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