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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. ZERO TIP DISLODGER, STONE, BASKET URETERAL, METAL

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BOSTON SCIENTIFIC CORP. ZERO TIP DISLODGER, STONE, BASKET URETERAL, METAL Back to Search Results
Model Number M086 3901056
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2019
Event Type  malfunction  
Event Description
Tip fell off in pt. Tip retrieved by dr.
 
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Brand NameZERO TIP
Type of DeviceDISLODGER, STONE, BASKET URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
MDR Report Key9224959
MDR Text Key163631261
Report NumberMW5090567
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 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM086 3901056
Device Lot Number23978813
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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