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

Catalog Number NTSE-015115

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

As reported, during a stone extraction procedure and using a ncircle tipless stone extractor, the basket failed to open.After using a laser to crush urinary stones, the user tested the function of the ncircle tipless stone extractor and confirmed that the basket opened/closed without issue.The stones were located in the urinary tract and kidney.Then they attempted to extract the stones using the device, but it did not open smoothly.The basket wires were tangling, so they removed the device from the patient's body.There was nothing noted in the patient's anatomy that would have caused the basket to be unable to open/close.The basket was unable to be opened.They replaced it with another new device to complete the procedure.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.The patient did not experience any adverse effects due to this occurrence.

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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event description: as reported, during a stone extraction procedure and using a ncircle tipless stone extractor, the basket failed to open.After using a laser to crush urinary stones, the user tested the function of the ncircle tipless stone extractor and confirmed that the basket opened/closed without issue.The stones were located in the urinary tract and kidney.Then they attempted to extract the stones using the device, but it did not open smoothly.The basket wires were tangling, so they removed the device from the patient's body.There was nothing noted in the patient's anatomy that would have caused the basket to be unable to open/close.The basket was unable to be opened.They replaced it with another new device to complete the procedure.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation / evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu), and quality control procedures.One ncircle tipless stone extractor was returned for investigation in an open package.Inspection of the returned device noted: the device was returned with the handle in the closed position and the basket formation was partially closed.The mlla [male luer lock adapter] was tight.The collet knob was tight.A functional test determined the handle did not actuate basket formation.The handle was disassembled during investigation.The basket formation could not be manually actuated.Under microscope, there appeared to be some sort of material on the basket assembly and inside the tip of the basket sheath.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents was conducted.All extractors are verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: the device is conductive.Avoid contact with any electrified instrument.Precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to have a basket that was partially closed and would not fully open or close.An unidentified material was observed on the wires of the basket.The material was preventing the basket wires from moving within the basket sheath.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 13638786
• MDR Text Key: 296076868
• Report Number: 1820334-2022-00325
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)241119(10)14366062
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 14366062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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
• Treatment: OLYMPUS URF-V2.