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 03/07/2017

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 procedure.The product in use was a ngage nitinol stone extractor.The attending physician indicated that the grasper would open but would not close prior to procedure.The physician stated that the procedure was completed successfully but with another device.No further information was provided.There was no adverse event.

Manufacturer Narrative

The device was not returned for evaluation, however a review of the following was completed: complaint history, device history record, manufacturing instruction, quality control, and specifications.The review found no other complaints associated with the complaint device lot number.A review of production and quality documentation revealed no specific issues that may have contributed to this incident.A review of the device history record revealed two non-conformances; however none of these were related to this failure.Based on the information provided a root cause could not be determined.We will continue to monitor for similar complaints.Per the 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6460077
• MDR Text Key: 71711760
• Report Number: 1820334-2017-00609
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)190908(10)7257300
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: NGE-022115-MB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: 06/27/2017
• Supplement Dates FDA Received: 07/26/2017
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1