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

Catalog Number	NGE-022115
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 or Problem Description
It was initially reported the ngage nitinol stone extractor basket did not open properly in the kidney.The patient was not harmed.The handle clicks, when opening the basket.The basket jumps open instead of opening smoothly.Additional information received on 30nov2018.The representative reported he talked to the customer again.Unfortunately, he could not give me the additional information requested.He described the incident as the following: flexible urs for stone treatment was performed.After deflecting the endoscope in the lower calyx, the ngage was advanced through the working channel to the fragment.The basket did not open properly in the calyx.They removed the ngage from the endoscope and made a dry functional test outside of the patient.The basket did not open smoothly but jumped open.The customer opened a second ngage.The procedure was completed successfully and the patient was not harmed.
Additional Manufacturer Narrative
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, the device history record, instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirmed the device lot number 8991688.The complaint device was returned with the handle and the basket formation in the closed position.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measured 3.8 cm in length.Visual examination noted the support sheath is bowed 1 cm from mlla.There are no kinks in the basket sheath.The support sheath and basket sheath are still adhered.Functional testing determined the handle does not actuate the basket formation.The handle was disassembled.The basket formation cannot be manually actuated.The coil assembly appears to be stuck inside the basket sheath.A review of the device history record for lot 8991688 found there were no non-conformances related to the reported failure.A review of complaint history records revealed there has been one other complaint received on device lot number 8991688; however, the other complaint was for an unrelated issue.According to 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.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.All devices are inspected for functionality and damage prior to packaging.The sheath damage prevented the basket from functioning normally.The damage likely occurred inadvertently during handling / use of the device.The likely cause is traced to the user; unintended use error caused or contributed to the event.Per the quality engineering risk assessment, no further action is warranted.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 or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8125872
• Report Number: 1820334-2018-03516
• Device Sequence Number: 1487585
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)210702(10)8991688
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2021
• Device Catalogue Number: NGE-022115
• Device Lot Number: 8991688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1