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 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported by the user facility that a patient was scheduled for an ureterorenoscopy procedure when the staff realized that the extracting element would not work as intended.The ngage nitinol stone extractor grasper was opened and prior to insertion checked for proper function.It was at that time the staff noticed that the gasper would not open.The device was placed back in the original packaging and another device was used to complete the procedure.No further information was provided.

Manufacturer Narrative

The device was returned the handle in the open position and the basket formation was partially open.A visual examination noted the support sheath is bent at the nose of the mlla.No kinks were noted in the basket sheath.A functional test was performed.The udh handle fully actuate the basket formation to open and closed positions.A review of the dhr showed 5 non-conformances associated with the complaint device lot number.Since some of the non-conformances are related to the complaint issue appropriate product and quality managers have been alerted.We will continue to monitor for similar complaints.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor 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: 6367630
• MDR Text Key: 68602361
• Report Number: 1820334-2017-00407
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)191128(10)7471557
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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