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

Catalog Number NGE-022115

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

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.(b)(6).Occupation: non health care professional.(b)(4).

Event Description

It was reported that while preparing for an unspecified procedure using a ngage nitinol stone extractor, the basket would not close and did not work at all from initial opening of the device.A second unspecified device was opened and the procedure was completed with no impact to patient care.Additional patient and event details have been requested; however no further information has been provided at this time.

Manufacturer Narrative

Additional information received 04dec2018 after submission of the initial medwatch report.

Event Description

Additional information received 14dec2018.This was a cysto with stone removal procedure.The basket never touched the patient, the issue was realized before it reached the patient.The stones were removed with alternate baskets.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Investigation/evaluation: visual inspection and functional testing of the returned device was conducted during the investigation.A review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data was also performed.One device was returned for investigation.The returned packaging confirms lot number 7471556.The device was returned with the handle in the closed position.The basket formation was returned partially closed.The male luer lock adapter (mlla) is tight.The collet knob is loose.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.A visual examination noted there are no kinks in the basket sheath.A functional test noted the handle does actuate the basket formation to the opened position, but does not close the basket formation completely.The support sheath and basket sheath are still adhered and secure.The handle was disassembled.When testing, the basket formation could be manually actuated.The handle was reset and reassembled.After reset, the handle actuates the basket formation to both the opened and closed positions.The device history record was reviewed and found no non-conformances that would have contributed to the reported failure mode.A review of complaint history revealed this is one of two complaints associated with lot number 7471556 for similar issues.The second complaint device was not returned for investigation; therefore, the complaint issue could not be confirmed.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Devices are inspected for damage and functionality prior to packaging.The complaint device was found to have a basket that would not close.The basket would open fully, but would not close fully when the handle was actuated.The handle was disassembled and it was found the basket could be fully closed when the cannulated handle was manually functioned without the handle attached.The device was reassembled and normal basket function was restored.This indicates the gap between the handle and handle cannula was not optimal, allowing the device to function when tested, but not to function after the device was packaged and shipped.The investigation conclusion is the cause is traced to the device design.Actions have been identified for this issue, but were not yet implemented at the time this device was manufactured.A quality engineer risk assessment concluded no risk further reduction activities are required.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: 8164662
• MDR Text Key: 130500678
• Report Number: 1820334-2018-03685
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)191128(10)7471556
• 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,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Catalogue Number: NGE-022115
• Device Lot Number: 7471556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 55