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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK UROLOGICAL INC. NCIRCLE TIPLESS STONE EXTRACTOR; DISLODGER, STONE, BASKET, URETERAL, METAL
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COOK UROLOGICAL INC. NCIRCLE TIPLESS STONE EXTRACTOR; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSE-030115-UDH
Device Problem Wire(s), breakage of (2347)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/20/2014
Event Type  malfunction  
Event Description
During a stone extraction procedure, a part of the basket broke and a small piece of the nitinol wire was left in the pt.Info was provided that the user is unsure as to what interventional action will be taken.According to the initial reporter, the pt did not experience any adverse effects due ot his occurrence.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
NCIRCLE TIPLESS STONE EXTRACTOR
Type of Device
DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK UROLOGICAL INC.
spencer IN 47460
Manufacturer Contact
rita harden, director
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key3850319
MDR Text Key4617854
Report Number1820334-2014-00123
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 Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2001,02/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2016
Device Catalogue NumberNTSE-030115-UDH
Device Lot NumberU2438953
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/13/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/2014
Device Age1 MO
Event Location Hospital
Date Manufacturer Received03/04/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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