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

Catalog Number NGE-017115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

The customer reported they have had an issue with the ngage basket not closing all the way.Additional patient, procedure and event details have been requested but have not been received at the time of this report.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned devices was conducted.A document based investigation was also performed which included a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.Two devices were returned for investigation.Device a: the device was returned with the handle and the basket formation in the closed position.The collet knob is tight and secure.The male luer lock adapter (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 3.7 cm in length.A functional test determined the handle actuated the basket formation.However, when the handle and basket formation are in closed positions, there is a small gap in the wires.Device b: the device was returned with the handle and the basket formation in the open positions.The collet knob is tight and secure.The mlla is finger tight.The pett measures 3.7 cm in length.A visual examination noted the support sheath is bowed in appearance.There were no kinks or damage observed in the basket sheath.A functional test determined the handle actuates the basket formation.It was noted that if the handle is over extended by pushing the slide all the way to the end, there is a gap noted, otherwise the basket formation closed fine.A review of the device history record found no non-conformances associated with the complaint device lot.A review of complaint history records revealed this complaint is the only one associated with lot number 8583440.The instructions for use (ifu) provides the following: 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.Two complaint devices were returned.Both devices were found to have slight issues with the baskets fully closing.No damage that could have caused functional issues was noted.Conclusion for this complaint is traced to manufacturing deficiency and supplier deficiency.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.

Event Description

Additional information provided on 21aug2018.There were two devices involved with this complaint.On (b)(6) 2018 customer advised that both devices were from the same lot (8583440).

• 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: 7702375
• MDR Text Key: 114425990
• Report Number: 1820334-2018-02133
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)210214(10)8583440
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: NGE-017115
• Device Lot Number: 8583440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1