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 Patient Involvement (2645)

Event Date 04/19/2017

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 during preparation of an unspecified procedure, the user discovered that the tip of the basket could not open prior to patient contact.The device in use was an ngage nitinol stone extractor.No further information was provided.

Manufacturer Narrative

A review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.One device was returned for investigation.The device was returned with the udh handle and the basket formation in the closed position.A visual examination noted the support sheath was slightly bowed in appearance.A functional test was performed and the udh handle would not actuate the basket formation.A visual examination noted the basket sheath had a kink 87 cm from the distal tip.The collet knob is tight and secure.The handle was disassembled, the mlla (male luer lock adaptor) was found to be loose.Two black specks fell out from the handle.The basket formation was manually actuated to the open and closed position.The udh handle was reset and reassembled.After the udh was reassembled, the device functioned fine and the udh handle actuated the basket formation to the open and closed position.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number.Based on the information provided and the results of our investigation a definitive root cause could not 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: 6568471
• MDR Text Key: 75211587
• Report Number: 1820334-2017-00929
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)191209(10)7505496
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• 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