MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number G48294

Device Problem Difficult to Open or Close (2921)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: site coordinator.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during a laser lithotripsy using a ngage nitinol stone extractor, "the stone extractor did not work, device would not release or retrieve basket." a new stone extractor was used to complete the procedure.There were no adverse effects to the patient reported as a result of this alleged product malfunction.The person who called in the event to customer relations had no further information, but did provide the name and phone number of a contact at the facility who could answer additional questions.A cook representative attempted to call this person at the number provided, and was informed that they were not allowed to transfer the call directly to an employee.Due to this occurrence, no other information could be obtained.

Manufacturer Narrative

Investigation/evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the correct device was returned.The device was received with the handle in the closed position but the basket formation in the open position.The male luer lock adapter was tight, with the collet knob loose.The polyethylene terephthalate tubing measuring 3.6cm in length.During the functional testing, the handle would not actuate the basket formation.The hand was then disassembled, reset, and reassembled.The functional test then noted the handle actuates the basket formation to the open position but did not close completely.There was a slight gap between the basket wires, making the basket formation appear as though it was being caught or pulled.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states all appropriate warnings, precautions, contraindications, and indications.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 8698407
• MDR Text Key: 148076275
• Report Number: 1820334-2019-01401
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)220221(10)9541620
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: 9541620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU
• Patient Age: 65 YR