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 Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

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 a flexible ureterorenolithotripsy using a ncircle tipless stone extractor, the extractor opened but would not close after the first use.The device broke, so another same type device was used 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 alleged malfunction.No adverse effects were reported due to the alleged malfunction.

Manufacturer Narrative

Event description: as reported, during a double j stent removal procedure, while removing the stent they discovered residual kidney stones, that remained from a previous surgical procedure, present in the lower kidney cup.An ncircle tipless stone extractor was used to remove these kidney stones.The doctor identified that the basket did not open correctly on the first stone removal attempt.The doctor continued using the extractor, but eventually the basket would not open and close.The doctor attempted to correct the issue by making adjustments to the handle.Another same type device was used 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 alleged malfunction.No adverse effects were reported due to the alleged malfunction.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 with the handle separated from the basket sheath and the coil assembly.There was 1.9 cm of the cannulated handle protruding from the nose of mlla [male luer lock adapter].The mlla was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.Examination of the basket sheath and coil assembly noted: the basket formation was open.There were multiple kinks in the basket sheath.The coil assembly was returned outside of the basket sheath.The basket assembly measured approximately 115.8 cm in length.There was a severed kink in the basket sheath 52.5 cm from the distal tip of the support sheath.The length of the coil assembly measured approximately 113.2 cm.The cannulated handle was straight, not bent.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 100% 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 open and could not be closed due to device damage.The sheath and basket assemblies were separated from the device handle.The sheath was kinked in multiple locations.The basket assembly had been removed from inside the sheath assembly.The provided information stated the issue occurred during use, which indicates the device functioned normally to be able to insert the device through the scope.It is possible the device was inadvertently damaged during use, but no information is known related to device handing, therefore the cause of the issue could not be conclusively determined.The risk analysis for this failure mode was reviewed, and it was determined that no actions are 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.

Event Description

Additional information was received 17feb2021: the procedure being performed was removal of a double j stent and not a flexible ureteroreno lithotripsy as initially reported.While removing the stent they discovered residual kidney stones, that remained from a previous surgical procedure, present in the lower kidney cup.The device was being used to remove these kidney stones.The doctor identified that the basket did not open correctly on the first stone removal attempt.The doctor continued using the extractor, but eventually the basket would not open and close.The doctor attempted to correct the issue by making adjustments to the handle.

• 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
• MDR Report Key: 11329759
• MDR Text Key: 232557840
• Report Number: 1820334-2021-00330
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)230818(10)13375373
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13375373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR