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 Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that a patient underwent an ureteroscopy with laser lithotripsy procedure.The device in use was the ngage nitinol stone extractor.The attending physician indicated that the stone extractor was deployed and used for extractions a couple of times before it would no longer completely close.The physician had repositioned the stone prior to the basket failure, and so instead of removing fragments with the basket, he used the laser to fragment the stones small enough to pass on their own.There were no additional procedures performed due to the basket not closing.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

A review of the complaint history, device history, documentation, and quality controls were completed.Visual inspection of the returned device and a functional test of the device were conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconformances.There were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.A functional test showed that the product functioned as intended.After 5 actuations, the udh handle still opened and closed the basket formation completely.The malfunction reported by the customer could not be reproduced during the investigation.Based on the provided information, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6445519
• MDR Text Key: 71217077
• Report Number: 1820334-2017-00516
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)200116(10)7594334
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NGE-022115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1