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

Catalog Number NGE-017115-MB

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Name and address: (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, prior to a ureteroscopy and stone removal using a ngage nitinol stone extractor, the basket would not open and close fully.The user was able to continue the procedure using the complaint device.No unintended device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Event description: it was reported, the basket of an ngage nitinol stone extractor was not opening and closing fully before use during a ureteroscopy and removal of stone procedure.Further communication with the user facility clarified that the complaint device was used to complete the procedure, but the basket was not functioning normally.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 (dhr), manufacturing instructions, the instructions for use (ifu), and quality control data.One ngage nitinol stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle and the basket formation in the open position.The mlla [male luer lock adapter] was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.0 cm in length.A functional test determined the handle did not actuate basket formation.The handle was disassembled.The basket formation could not be manually actuated.There was evidence of adhesive on the basket sheath inside the support 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 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: suggested handling instructions for extractors and forceps caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.Glue residue was observed on the proximal end of the basket sheath where it is visible as it exits the orange support sheath flair.The basket sheath and support sheath are glued together during manufacturing, so the presence of glue was expected.It is possible that some glue residue, or other unknown material, was stuck between the inside of the basket sheath and the basket wire and as the device was functioned, the material moved and gradually affected the ability of the basket to function until the basket would no long function at all.The presence of material between the basket sheath and basket wire was not confirmed, therefore the conclusion of the investigation was that 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.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: NGAGE NITINOL 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: 10942685
• MDR Text Key: 223773106
• Report Number: 1820334-2020-02232
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482958
• UDI-Public: (01)10827002482958(17)230812(10)13363335
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 13363335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXOR URETERAL ACCESS SHEATH; OLYMPUS FLEXIBLE URETERENSCOPE