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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 07/06/2018
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) # - exempt. (b)(4). 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 on (b)(6) 2018, the ncircle tipless stone extractor ((b)(4)) was used for a procedure and a ureteral injury was confirmed after/during a procedure. It is unknown exactly what caused the injury. Additional information was received on (b)(6) 2018 in response to follow up for additional event information. Degree of injury and how it occurred are not known yet. It seems that the doctor doesn't think the (b)(4) caused the injury or had a breakage or defect. However he wants cook the manufacturer to investigate the device in question to see there is a breakage or defect. Additional information was received on (b)(6) 2018, in response to manufacturer's request for other devices/medications used during the procedure. As reported, a rigid ureteroscope (maker and model unknown), a laser fiber (lumenis¿ slimline fiber) and some guide wires should have been used.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7762624
MDR Text Key116420114
Report Number1820334-2018-02438
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 company representative,foreig
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/07/2020
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number8120417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2017
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: 08/08/2018 Patient Sequence Number: 1
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