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	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: 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, prior to the procedure, the physician tested the ngage nitinol stone extractor and found it would not open.Therefore, they changed to a new one and it opened.No adverse events have been reported as a result of the alleged malfunction.
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, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The device was returned with the handle and basket formation in the closed positions.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.A visual examination noted the support sheath is bowed in appearance.The basket sheath is kinked at the distal tip of the support sheath.A functional test determined the handle actuates the basket formation.With the basket formation in open position, the width of the basket formation measures 9 mm.The handle actuates the basket formation to open and closed positions without issue.The support sheath and basket sheath are still adhered.A review of the device history record found there were no non-conformances related to the reported failure.A review of complaint history records revealed no other complaint has been reported for lot number 8449401.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.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 returned complaint device was found to have a basket that opened and closed normally when the handle was functioned.The reported issue that the device would not open was not confirmed.Damage to the sheath of the device was noted: the support sheath was bowed and the basket sheath was kinked near the distal tip.The observed damage did not affect functioning of the basket.There was no mention of device damage included in the event information.It is likely the damage occurred during return handling or return shipping of the device.The complaint that the basket would not open could not be confirmed and the observed sheath damage traced to transport/storage.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.
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: 7899318
• Report Number: 1820334-2018-02782
• Device Sequence Number: 285014
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)201215(10)8449401
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 12/15/2020
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 8449401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 84