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 04/05/2017

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 area representative that a patient underwent an ureteroscopy stone extraction procedure.The device in use was an ngage nitinol stone extractor.The staff stated they had closed the stone extractor and it would not open again.Additional questions were asked regarding the patient's outcome after the basket would not open, whether or not any additional procedures were done after the basket would not open, and the event information regarding what happened before and after the basket would not open.However, no further information was provided.

Manufacturer Narrative

The complaint device was returned and underwent visual inspection and functional testing.A review of the following was also completed to assist with the investigation: complaint history, device history record, quality control, and trends.The device was returned in the shipping tray.The device was returned with the udh in the closed position and the basket formation partially open.The black pin vise knob was tight and secure.The support sheath and the basket sheath are adhered together.The support sheath is straight.The basket sheath was checked and there were no kinks, bends, or damage noted.A functional test was performed and the udh handle actuated the basket formation to the fully open position.Initially, the basket formation only partially closed.But after three actuations, the basket formation snapped closed and continued to close accordingly with additional actuations.The handle slide knob goes all the way to the end of the allow space.Review of the device history record of the finished product shows ten nonconforming events for "does not function", which may be related to this failure mode.There were no other reported complaints for this lot number.Based on the provided information and evaluation of the returned device, a definitive root cause cannot be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6536507
• MDR Text Key: 74181500
• Report Number: 1820334-2017-00824
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)191108(10)7425526
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1