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

Catalog Number NGE-017115-MB

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 01/15/2018

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 the specialist tested the ngage nitinol stone extractor prior to use and it would open and close.Once placed down the scope and inside of the patient, the device would not open.Additional event, patient and device information has been requested; however, no new information has been provided at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation: evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data and specifications.No issues were identified that are related to the reported complaint.A visual inspection and functional testing of the returned device was also conducted during the investigation.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation is in the closed position.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.A functional test determined the handle actuates the basket assembly up and down, but it does not open and close the basket formation.The handle was disassembled.The basket formation can be manually actuated.The handle was reset and reassembled and the device functioned as intended.A review of the device history record found no non-conformances associated with the complaint device lot number 8400430.A review of complaint history found this to be the only complaint associated with product lot number 8400430.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.These devices are 100% inspected for functionality and integrity before packaging.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.The ifu contains a caution to not use excessive force to manipulate the device, or damage to the device may occur.The cause for the device to not function when received could not be determined.No damage or other issues were observed with the returned device.The root cause of this event could not be determined.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.

• 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: 7222919
• MDR Text Key: 98602777
• Report Number: 1820334-2018-00212
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482951
• UDI-Public: (01)00827002482951(17)201128(10)8400430
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115-MB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1