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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL / COOK, INC. NCIRCLE MITINOL TIPLESS STONE EXTRACTOR

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COOK MEDICAL / COOK, INC. NCIRCLE MITINOL TIPLESS STONE EXTRACTOR Back to Search Results
Model Number NTSE-022115-UDH
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 09/21/2018
Event Type  malfunction  
Event Description
While operating the device, the basket being used broke.
 
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Brand NameNCIRCLE
Type of DeviceMITINOL TIPLESS STONE EXTRACTOR
Manufacturer (Section D)
COOK MEDICAL / COOK, INC.
bloomington IN 47404
MDR Report Key7984289
MDR Text Key124594317
Report NumberMW5080689
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 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2018
Device Model NumberNTSE-022115-UDH
Device Catalogue NumberG18778
Device Lot Number9045701
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

Patient Treatment Data
Date Received: 10/18/2018 Patient Sequence Number: 1
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