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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number M0068407170
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2019
Event Type  malfunction  
Event Description
During percutaneous nephrolithomy case, md was using ultrasound lithotripsy to break up kidney stones. The ultrasound probe used to operate the lithotripsy within the nephroscope broke in half midway through the procedure. The broken piece was removed from the sterile field, and a new ultrasound probe was given to md.
 
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Brand NameULTRASOUND PROBE
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8455209
MDR Text Key139999378
Report Number8455209
Device Sequence Number1
Product Code FFK
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 03/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0068407170
Device Catalogue NumberM0068407170
Device Lot Number23023809
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2019
Event Location Hospital
Date Report to Manufacturer03/27/2019
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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