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

Catalog Number NGE-022115

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

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 was reported, during ureteroscopic holmium laser lithotripsy, the user smashed the stone by lithotripsy and successfully removed stones twice using a ngage nitinol stone extractor.On the third attempt to remove stones it was discovered that a basket wire broke.Another device was used to complete the procedure.No section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: cook was informed of an incident involving a ngage nitinol stone extractor.The basket wire of the device reportedly broke during a ureteroscopy holmium laser lithotripsy procedure.Further communication with the user facility clarified that the device functioned normally and removed 2 stones.During removal of the 3rd stone, it was found the basket wire was broken.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, documentation, drawing, the instructions for use, manufacturing instructions, and quality control data.The device was returned with the handle and the basket formation in the open position.The basket formation had several broken wires.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 4 cm in length.The support sheath was straight.There was charring noted on the broken wires.A review of complaint history records shows one other complaint associated with the complaint device lot.The two complaints were for different failure modes.Therefore, there was no indication of a common issue that would have indicated that other devices in the lot could be nonconforming.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: caution: this device is conductive.Avoid contact with any electrified instrument.The returned device was found to have a severely damaged basket.The wires of the basket were separated and charring was observed.This indicates the wires of the device were exposed to an electrified instrument during use.The provided information stated a laser was not in use at the same time as the basket, but the nature of the damage indicates exposure to some type of electrified device, contrary to the cautions of the ifu.The cause of the issue was determined to be an unintended user error.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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.

• 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: 10948854
• MDR Text Key: 223773565
• Report Number: 1820334-2020-02242
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)230724(10)13327858
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Catalogue Number: NGE-022115
• Device Lot Number: 13327858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1