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

Catalog Number	NGE-022115-MB
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
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 reported during a retrograde intrarenal surgery (rirs), the physician tried to use the ngage nitinol stone extractor to grab the stone, but they found the basket cannot close.So, they changed to a new one to complete the procedure.The patient outcome was good.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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, quality control data, and specifications.One stone extractor was returned for investigation.The returned packaging confirmed lot number 8944968.The device was returned in the shipping tray.Functional testing found the handle does not actuate the basket formation while the device is still in tray.The device was returned with handle in open position and the basket formation in open position.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.Visual examination noted there is no damage in the basket sheath.Functional testing noted with the basket sheath in the straight position, the basket formation fully expands, but in closed position, the basket formation gaps 3 mm.The handle was disassembled.The support sheath and basket sheath are still adhered.The basket formation can be manually actuated.The handle was reset, and reassembled.The handle now actuates the basket formation to the fully open and fully closed positions.A review of the device history record found there were no non-conformances associated with the complaint device lot number.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 8944968.As found in 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.The complaint device was found to have a basket that would not fully close.No damage to the device was found.The handle was disassembled, and it was found the basket could be fully opened and closed by manually moving the cannulated handle.The device was reassembled with the gap adjusted, and full basket function was restored.Measures have been identified for the issue, but were not yet implemented at the time this device was manufactured.The investigation conclusion is cause traced to device design.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.

• 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: 7828387
• Report Number: 1820334-2018-02610
• Device Sequence Number: 16465592
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)210612(10)8944968
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 06/12/2021
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 8944968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/01/2018
• Patient Sequence Number: 1