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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: 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 that the ngage nitinol stone extractor was not working properly during a laser nephrolithotripsy.A section of the device did not remain 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

Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.The device has a used appearance with the presence of bio debris observed on the basket formation.The device was returned with the handle in the closed position.With the basket formation in closed position, there is a 1 mm gap in the wires.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3.7 cm in length.A visual examination noted kinks in the basket sheath at the following locations; there is a kink 36 cm from the distal tip, again at 60.5 cm, 81 cm, and 86 cm.A functional test determined the handle does not actuate the basket formation.The handle was disassembled and the basket formation cannot be manually actuated.The device history lot record was reviewed and noted there were no non-conformances associated with the reported failure.A search of complaint records found this is the only complaint associated with lot number 7494147.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.The instructions for use (ifu) contains the following cautions for device handling in order to prevent damage: 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 basket that would not open due to sheath damage.The sheath was found to be kinked in multiple locations.The kinks prevented the basket subassembly from moving freely within the sheath when the handle was operated.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use of the device.The likely cause for this issue was product use or handling related.This device received excessive pressure, causing the observed kinks.Per the quality engineering risk assessment, no further action is 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.

Event Description

It was reported that the ngage nitinol stone extractor was not working properly during a laser nephrolithotripsy.A section of the device did not remain 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.Additional information received.The ngage nitinol stone extractor was tested before use.This device was not used on the patient.The ngage nitinol stone extractor was replaced and a new device was used to complete the procedure.

• 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: 7582358
• MDR Text Key: 110484905
• Report Number: 1820334-2018-01686
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)191206(10)7494147
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Model Number: N/A
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 7494147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STOZ X2 SCOPE