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 11/20/2020

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, while testing a ngage nitinol stone extractor prior to a procedure, the basket failed to open.Another device was used to complete the procedure.No adverse effects were reported due to the alleged malfunction.

Manufacturer Narrative

Event description: as reported, while testing a ngage nitinol stone extractor prior to a procedure, the basket failed to open.Another device was used to complete the procedure.No adverse effects were reported due to the alleged malfunction.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 in the open position and the basket formation in the closed position.The mlla [male luer lock adapter] was tight.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.5 cm in length.When the handle was in the closed position, there was a 9 mm gap between the black slide and white end of the handle.There was glue on the basket sheath.There were kinks in the basket sheath 34.8 cm from the mlla, 53.3 cm from the mlla, 75.1 cm from the mlla, and 30 cm from the distal tip.A functional test determined the handle actuates basket formation, but it pops when in the open position.When the basket sheath was curved circular, the handle did not actuate the basket formation.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.The returned device was found to have a basket that would not function when the sheath was in a looped configuration.The sheath was kinked in multiple locations, which affected the ability of the basket to open/close normally.The issue was discovered prior to use.Device is inspected multiple times for functionality and damage during manufacturing and quality control checks.It is likely that the sheath of the device was inadvertently damaged during unpacking or subsequent handling before use.No information was provided, related to the handling of the device, therefore the cause for the damage could not be 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.

Event Description

There is no new patient or event information to report.

• 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: 10929340
• MDR Text Key: 219168763
• Report Number: 1820334-2020-02213
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)230930(10)13461846
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: NGE-022115
• Device Lot Number: 13461846
• 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