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

Catalog Number NGE-017115-MB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: exempt.(b)(4).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 preoperative testing, the basket on a ngage nitinol stone extractor was observed to be deformed.An alternative device was used to completed the procedure.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

Manufacturer Narrative

Evaluation / investigation: a visual inspection and functional testing of the returned devices was conducted.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation was in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 4 cm in length.A functional test determined the handle actuates the basket formation.A visual examination noted the basket formation is smashed and one wire does not retract properly.A review of the device history record found there were no non-conformances related to the reported failure.A review of complaint history for this device lot revealed this complaint is the only one associated with lot number 7906345.Per the instructions for use (ifu): 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.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.The complaint device was found to have a deformed basket.Devices are inspected for damage and functionality prior to packaging.Quality checks the function of the basket 5 times and also checks the shape of the basket.It could not be determined if the basket was deformed before being removed from the packaging, or if the basket became deformed during handling of the device after being removed from the packaging.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and 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.

• 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: 7377175
• MDR Text Key: 103749335
• Report Number: 1820334-2018-00811
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482951
• UDI-Public: (01)00827002482951(17)200512(10)7906345
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115-MB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1