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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 Problems Break (1069); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/28/2022
Event Type  Injury  
Manufacturer Narrative
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
As reported, while using a circle tipless stone extractor, the forceps broken while inside of the patient. The basket separated from the rest of the device. A new product was used to complete the procedure. No clinical impact noted, but the procedure took longer than expected. Additional patient outcome and event information has been requested.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13516042
MDR Text Key294867960
Report Number1820334-2022-00205
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)220606(10)9791901
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/06/2022
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number9791901
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
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