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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE DISLODGER, STONE, BASKET

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BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE DISLODGER, STONE, BASKET Back to Search Results
Model Number M0063801070
Device Problems Material Frayed (1262); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2017
Event Type  malfunction  
Event Description
A boston scientific segura 2. 4 french stone basket was opened for the case. When tested, the basket malfunctioned due to a frayed spot on the cable. This happened on the sterile field, not inside of the patients ureter. New product was opened and used for the case.
 
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Brand NameSEGURA HEMISPHERE
Type of DeviceDISLODGER, STONE, BASKET
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key6759705
MDR Text Key81594276
Report Number6759705
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2019
Device Model NumberM0063801070
Device Lot Number19064957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer07/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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