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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter: (b)(6).Pma/510(k) #- 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, the tip of the basket of an ncircle tipless stone extractor separated from the device during a right flexible ureteroscopy.This was discovered at the end of the procedure.The surgery was prolonged to retrieve the separated basket tip from the patient and reinsert a stent.There was no patient harm as a result of this event.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: h6: component code (annex g) event description: as reported, the tip of the basket of an ncircle tipless stone extractor separated from the device during a right flexible ureteroscopy.This was discovered at the end of the procedure.The surgery was prolonged to retrieve the separated basket tip from the patient and reinsert a stent.There was no patient harm as a result of this event.Investigation ¿ evaluation a visual inspection 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 data.One ncircle tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned in an open outer package.The handle was in the open position.The basket formation was returned detached from the basket assembly.The mlla [male luer lock adapter] was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.There were multiple kinks in the basket sheath.The support sheath was curved.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows two other related complaints associated with the complaint device lot.It is possible the same failure occurred for all 3 devices.All 3 complaints were reported by the same customer.All basket assemblies are pull tested during manufacturing, an issue that affected the devices from the lot would be highly unlikely.Because there were no related non-conformances, adequate inspection activities had been established, and there was objective evidence that the dhr was fully executed, it was concluded that there was no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents was conducted.The basket assemblies are pull tested to ensure integrity.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: 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 the basket separated.The basket wires broke proximal of the basket cannula.The cause for the damage is unknown.Excessive force may have been inadvertently applied to the device, however no information was known regarding device handling, therefore the cause of the issue could not be conclusively determined.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: 13294414
• MDR Text Key: 284537122
• Report Number: 1820334-2022-00087
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)241022(10)14300027
• 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,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 14300027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• 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
• Patient Outcome(s): Required Intervention