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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC

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BOSTON SCIENTIFIC CORP. SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number M0068402910
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  malfunction  
Event Description
While in use per manufacturer's instructions, the boston scientific swiss lithoclast trilogy disposable probe broke in half during use. Probe broke (cleanly) while within the nephroscope and was immediately recovered and removed from the field. Company representative (b)(4) present. Fda safety report id (b)(4).
 
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Brand NameSWISS LITHOCLAST TRILOGY DISPOSABLE PROBE
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
marlborough MA 01752
MDR Report Key8515271
MDR Text Key142196393
Report NumberMW5085865
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/10/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberM0068402910
Device Catalogue NumberM0068402910
Device Lot Number166562A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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