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U.S. Department of Health and Human Services

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

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COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSED-024115-UDH
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) number: exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during a urinary stone extraction procedure, the handle of an ncircle delta wire tipless stone extractor would not actuate the basket formation smoothly. The basket was tested prior to insertion into the scope and opened and closed with no issue. After the device was used twice to extract stones, the handle did not move smoothly. The device was replaced with another to complete the procedure. The patient did not experience any adverse effects due to this occurrence.
 
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Brand NameNCIRCLE DELTA WIRE 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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11090729
MDR Text Key224390736
Report Number1820334-2020-02379
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002191102
UDI-Public(01)10827002191102(17)230911(10)13424313
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSED-024115-UDH
Device Lot Number13424313
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2020
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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