MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NTSE-022115-UDH

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: quality manager.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.

Event Description

As reported, during a stone removal procedure, the basket of a ncircle tipless stone extractor became stuck within the patient's ureter.The physician cut the basket head off of the device, leaving it in the patient while withdrawing the proximal end.A stent was placed, and the procedure was completed.A follow-up laser ureteroscopy was later performed, during which the basket head was successfully removed from the patient.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This event is a duplicate of 1820334-2022-01227.All information for this event will hereafter be reported under 1820334-2022-01109.Event summary as reported, during a stone removal procedure, the basket of a ncircle tipless stone extractor became stuck within the patient's ureter.The physician cut the basket head off of the device, leaving it in the patient while withdrawing the proximal end.The basket was alternatively described as having separated within the ureter.A stent was placed, and the procedure was completed.A follow-up laser ureteroscopy was later performed, during which the basket head was successfully removed from the patient.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ based on the available information, cook has concluded that a cause for this event could not be established.The basket may have detached due to forces applied during use, or it may have been intentionally cut by the user.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.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.

Event Description

Additional information received 23aug2022.This event is a duplicate of 1820334-2022-01227.The following information was reported under this report.As reported in mw5110277, an ncircle tipless stone extractor separated when attempting to extract a kidney stone.As the physician attempted to remove the device from the patient with a kidney stone in the basket, the physician tugged on the device, and the tip of the basket separated within the right ureter.The basket tip could not be retrieved despite the attempted use of two other baskets.The basket and kidney stone were retained within the right ureter.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Type of Device: FFL 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 Key: 14786788
• MDR Text Key: 294595092
• Report Number: 1820334-2022-01109
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)250406(10)14650212
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 14650212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention