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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
Zero tip basket broke during stone retrieval. Fda safety report id# (b)(4).
 
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Brand NameDISLODGER, STONE, BASKET, URETERAL, METAL
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key10128368
MDR Text Key194684299
Report NumberMW5094876
Device Sequence Number1
Product Code FFL
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 06/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901050
Was Device Available for Evaluation? No
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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