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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
As reported, during a ureteroscopy, an ncircle delta wire tipless stone extractor would not fully open when testing the device upon removal from the packaging. A wire inside the basket appeared bent. Another same type device was used to successfully complete the procedure. The patient did not require any additional procedures due to this occurrence. The complainant has not reported any adverse effects on the patient due to this occurrence. Additional event information has been requested.
 
Manufacturer Narrative
Name and address: postal code: (b)(6). Occupation: purchasing agent. Pma/510k #¿ exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
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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 Key13921243
MDR Text Key292507010
Report Number1820334-2022-00458
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSED-024115-UDH
Device Lot Number13861382
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2021
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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