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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-045065-UDH
Device Problem Break (1069)
Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2021
Event Type  malfunction  
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
As reported, during a laparoscopic choledocholithotomy due to biliary calculi, the basket of an ncircle tipless stone extractor broke while removing a stone. The stone was was unable to be removed with the device and a second device from the same lot number was used to remove the stones successfully. The alleged malfunction caused the procedure to be delayed and resulted in "wound injury" to the patients' common bile duct. No section of the device remained inside the patients body. The patient did not require any additional procedures due to this occurrence. No additional patient consequences were reported. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been 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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12267286
MDR Text Key264818840
Report Number1820334-2021-01911
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-045065-UDH
Device Lot Number13506671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2020
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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