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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ULTRASOUND LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Catalog Number M0068407170
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2019
Event Type  malfunction  
Event Description
Patient was receiving a left percutaneous nephrolithotripsy and the ultrasound probe broke in half. We found a new probe and turned the information into ordering because we only have the two on hold, so both were in use. The charge nurse and risk management were called. The instrument and packaging was turned in.
 
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Brand NameULTRASOUND
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key8669734
MDR Text Key147032218
Report Number8669734
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 Risk Manager
Type of Report Initial
Report Date 05/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM0068407170
Device Lot Number08714729516613
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2019
Event Location Hospital
Date Report to Manufacturer06/05/2019
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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