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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2022
Event Type  malfunction  
Event Description
It was reported that a patient was undergoing a transurethral cystoscope lithotripsy for treatment of dysuria and hematuria when it was noted that the blue catheter at the handle of a ncircle tipless stone extractor basket was torn and broken and the basket could not be opened and closed. A new device was used to complete the procedure. A section of the device did not remain inside the patient¿s body. The patient did not require any additional intervention due to this occurrence. The patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Initial reporter occupation
=
unknown. Pma/510(k) number
=
exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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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 Key14688556
MDR Text Key301984566
Report Number1820334-2022-01055
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002175201
UDI-Public(01)10827002175201(17)240805(10)14133730
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-045065-UDH
Device Lot Number14133730
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received08/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2021
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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