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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
Model Number G18778
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/07/2019
Event Type  Injury  
Manufacturer Narrative
Pma/510k # exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It is reported, during a flexible ureteroscopy, using a ncircle tipless stone extractor, the basket detached from the forceps. The head of the extractor remained in the patient's kidney. The physician tried to remove it with a multi use retrieval forceps, but it was not long enough. The patient is scheduled for a second procedure in 2 weeks to remove the retained section of the device. No additional consequences to the patient have been reported as a result of this alleged product malfunction. Additional details regarding the patient and event have been requested. At this time, no additional information has provided.
 
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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 Key8632550
MDR Text Key145790852
Report Number1820334-2019-01170
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/12/2022
Device Model NumberG18778
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number9514838
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2019
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: 05/22/2019 Patient Sequence Number: 1
Treatment
LASER, FLEXIBLE URETEROSCOPE
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