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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION LITHOVUE URETEROSCOPE AND ACCESSORIES, FLEXIBLE Back to Search Results
Catalog Number M0067913500
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2019
Event Type  malfunction  
Event Description
The device would not communicate with lithovue machine. A new device was obtained and the procedure continued without further issues.
 
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Brand NameLITHOVUE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
100 boston scientific way MA 01752
MDR Report Key9224187
MDR Text Key163326716
Report Number9224187
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874805
UDI-Public8714729874805
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 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM0067913500
Device Lot Number24113410
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2019
Event Location No Information
Date Report to Manufacturer10/23/2019
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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