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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a transurethral lithotripsy (tul) procedure, the user tested the ncircle tipless stone extractor by trying to open/close the basket but it did not move as intended.The issue with this device was discovered prior to making contact with the patient and it was not used.Another ncircle tipless stone extractor was used to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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

The lot number was provided on 29may2020 after our initial mdr was submitted.Additional information was received 03jun2020: the basket could be opened/closed, but the user felt something was wrong with the basket when he was opening/closing it.There were no adverse effects to the patient.

Manufacturer Narrative

Event description: it was reported on (b)(6) 2020 of an incident involving a ncircle tipless stone extractor.The basket of the device reportedly would not move as intended before use during a transurethral lithotripsy (tul) procedure on (b)(6) 2020.Another ntse-015115 was used to complete the procedure.Further communication with the user facility clarified that according to the customer, the basket could be open/closed but he felt something wrong with the basket when he was moving the basket.The patient reportedly experienced no harm as a result of the issue.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, the instructions for use, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned for investigation.The device was returned with the handle and the basket formation in the closed position.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.6 cm in length.The basket sheath had a smashed spot that measured 5mm in length.There was a kink in the basket sheath 57.5cm from the distal tip.The distal tip of the basket sheath kinked within the first centimeter of the device.The basket formation was smashed.Function test determined the handle actuates the basket formation.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.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.Do not use excessive force to manipulate this device.Damage to the device may occur.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a basket that would open and close when the handle was functioned, but when in the open position, the wires of the basket did not form the proper basket shape.The basket shape was oval and not round.Sheath damage was noted, specifically the basket sheath was kinked near the distal tip, where the basket is located when in the closed position.It is possible that the sheath was damaged with the basket in the closed position, which caused the basket to become damaged and misshapen.The provided information stated the issue occurred before patient contact.It is possible the device was damaged during unpacking and/or subsequent handling.It is also possible that the device was damaged during shipping, or when loading the device into the device tray.There is not enough evidence to make a conclusion as to the cause of the damage.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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

No new patient or event information since the last report was submitted.

• 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: 10100530
• MDR Text Key: 196584688
• Report Number: 1820334-2020-01012
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2023
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 13085421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1