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

Catalog Number NGE-022115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

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

It was reported, during ureteroscopic holmium laser lithotripsy, the user smashed the stone by lithotripsy and successfully removed stones using a ngage nitinol stone extractor.On the second attempt to remove stones, it was discovered that the basket would not close smoothly.Another device was used to complete the procedure.No section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a ngage nitinol stone extractor.The basket wire of the device reportedly could not be closed smoothly during a ureteroscopic holmium laser lithotripsy procedure.Further communication with the user facility clarified that the device functioned normally for one stone removal, but then could not be closed for the second attempt.Another device was used to complete the procedure.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.The device was returned with the handle and the basket formation in the open position.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 3.9 cm in length.Visual exam noted the handle slightly pops when moving to the closed position, and the basket formation did close completely.Function test determines the handle actuates the basket formation.A review of complaint history records shows one other complaints associated with the complaint device lot.The other complaint was reported for a non-similar issue from the same customer.The two complaints were for different failure modes therefore, there was no indication of a common issue that would have indicated that other devices in the lot were nonconforming.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.The returned device was found to have a basket that would open and close as the handle was functioned, but it was noted that the handle slightly popped when moving to the closed position.This indicated that components inside the device were interfering with each other during the closing motion.It was also stated by the user that the device functioned normally when removing the 1st stone.The evidence indicates the basket became slightly damaged internally between removing the 1st and 2nd stones.It is possible that procedural factors such as patient anatomy, the locations of the stones, and/or user technique could have caused or contributed to the damage, but there was not enough evidence or information available to determine 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: 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: 10949278
• MDR Text Key: 223773717
• Report Number: 1820334-2020-02243
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)230724(10)13327858
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Catalogue Number: NGE-022115
• Device Lot Number: 13327858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1