MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR

Catalog Number NGE-022115

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

The reporter provided that the patients were male and female.The reporter stated the patients¿ ages were (b)(6).The reporter also provided the weights of (b)(6).However, it was not clear from the reporter which demographics matched which patient.Please see medwatch numbers 1820334-2017-00433, 1820334-2017-00432, 1820334-2017-00434 for the additional devices from this event.(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 two patients underwent a right flexi urs lower calyx, middle calyx and upper calyx procedure.The device in use for both procedures was an ngage nitinol stone extractor.The reporter stated that there were four baskets used, all with different lot numbers.There was no information as to which basket was used with which patient or how many were used for each procedure.It was reported that the baskets could not open or close during the rirs procedure.It was stated that the patients did not require any additional procedures.There were no unintended sections of the device that remained inside of either of the patients¿ bodies, nor did the patients experience any adverse effects due to these reported events.No further information was provided.

Manufacturer Narrative

A review of the complaint history, device history record, manufacturing instruction, and quality control, and a functional test and visual inspection of the returned device were conducted during the investigation.A document based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device was returned inside the packaging tray.The basket sheath was noted to be trapped under the lid of the shipping tray.The device was returned with the udh handle in the closed position and the basket formation in the partially open position.The support sheath and the basket sheath were found to be secure.The pin vise knob was noted to be tight and secure.A functional test was performed and the basket formation was found to completely open with the handle in the open position, but when the handle was in the closed position; the basket formation does not close completely.A visual examination noted the basket sheath had damage from being trapped in the tray and was noted from the distal tip of the basket sheath.Based on the information provided, a 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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6395884
• MDR Text Key: 69995410
• Report Number: 1820334-2017-00431
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)190222(10)6752526
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• 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: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-022115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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