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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 07/19/2019
Event Type  malfunction  
Event Description
Disposable probe broke 1/3 of the way down from handle (boston scientific corp 840-717 swiss lithoclast 3. 8 mm 403 mm ultrasound flexible probe latex free).
 
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Brand NameULTRASOUND PROBE
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key8821447
MDR Text Key152082910
Report Number8821447
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 07/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0068407170
Device Catalogue Number840-717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/23/2019
Event Location Hospital
Date Report to Manufacturer07/24/2019
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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