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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 Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Occupation: operating room purchasing. Pma/510k # exempt. A follow up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during stone removal in the ureter, when the package of an ncircle tipless stone extractor was opened, they found an extra piece of metal on the basket. No section of the device remained inside the patient's body. 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.
 
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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 Key12843200
MDR Text Key283671016
Report Number1820334-2021-02520
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 01/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number14222235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2021
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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