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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSE-022115-UDH
Device Problem Separation Problem (4043)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that during a ureteroscopy with stone extraction, an ncircle tipless stone extractor was in use, but found not to close completely. Then when attempting to withdraw the device from the endoscope the tip broke off. The bladder was then flushed to remove the separated portion. Another same device was opened to complete the procedure. It was reported that no portion of the device were left within the patient and the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameNCIRCLE TIPLESS STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9888167
MDR Text Key197143244
Report Number1820334-2020-00700
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number10232796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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