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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-015115
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 transurethral lithotripsy (tul), the user inserted a ncircle tipless stone extractor into the scope and opened the basket once and the basket would not close. There was nothing with the patient¿s anatomy keeping the basket from opening or closing. Another same type device was used to complete the procedure. The patient did not experience any adverse effects 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
8128294891
MDR Report Key13117349
MDR Text Key282957234
Report Number1820334-2021-02750
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,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberNTSE-015115
Device Lot Number14255027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2021
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: 12/30/2021 Patient Sequence Number: 1
Treatment
OLYMPUS P7 3.6 FR SCOPE
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