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 Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

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.

Event Description

As reported, the basket of a ncircle tipless stone extractor failed to open or close properly.No adverse effects have been reported due to this occurrence.The user facility stated that no further information about the event is available.

Manufacturer Narrative

Event description: as reported, the basket of a ncircle tipless stone extractor failed to open or close properly.No adverse effects have been reported due to this occurrence.The user facility stated that no further information about the event is available.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 data.One ncircle tipless stone extractor was returned for investigation with the handle in the open position.The basket formation was not visible and could not be seen at the distal end.The mlla [male luer lock adapter] was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.7 cm in length.A functional test determined when the handle was actuated, the basket formation did not exit the distal end.The cannulated handle was bent approximately 6 mm from the mlla.The support sheath and the basket sheath were severed at the mlla.The basket sheath and the support sheath were loose on the coil assembly.The coil assembly was bent at the junction of the cannulated handle.The coil was offset.The handle was disassembled during investigation.The cannulated handle appeared straight.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 related 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: 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 non-functional due to extensive sheath damage.The yellow support sheath and basket sheath were both separated at the handle, preventing the basket from being opened or closed.There was not enough evidence available to make a determination of the cause of the issue.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

There is no new patient or event information to report.

• 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: 11575082
• MDR Text Key: 244429633
• Report Number: 1820334-2021-01025
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)231014(10)13489785
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13489785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1