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

Catalog Number NGE-017115

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a transurethral lithotomy, a ngage nitinol stone extractor was deformed.The device was tested prior to use.Using an ureteroscope, the user crushed the stones in the upper urinary tract using a laser and retracted those stones using the device.The basket of the device deformed after this first retraction.The device was replaced with another of the same product reference number to complete the procedure.A section of the device did not remain 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.

Manufacturer Narrative

Event description: as reported, during a transurethral lithotomy, a ngage nitinol stone extractor was deformed.The device was tested prior to use.Using an ureteroscope, the user crushed the stones in the upper urinary tract using a laser and retracted those stones using the device.The basket of the device deformed after this first retraction.The device was replaced with another same type device to complete the procedure.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu) , and quality control data.One ngage nitinol stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle and the basket formation in the open position.The mlla [male luer lock adapter] was tight and the collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.5 cm.The support sheath was slightly bowed.There were no kinks or damage to the basket sheath.The wires in the basket formation appeared smashed and flattened.A functional test determined the handle does not actuate basket formation to the closed position.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records found one other complaint associated with the complaint device lot number (reference mdr # 1820334-2020-01749).This other complaint was reported from the same customer for the same issue that occurred during a different procedure.Analysis of both devices found the baskets were deformed.Both baskets were tested before use, indicating the damage occurred during use.It was concluded the devices were damaged during use and that there is no indication that the devices, or other devices in the lot, were nonconforming.Because there were no related non-conformances, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: suggested handling instructions for extractors and forceps caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.The returned device was found to have a deformed basket.The basket had the appearance that the wires may have been caught on an unknown object, or were subjected to excessive force that caused deformation of the basket.Functional testing found the basket would not open/close due to the deformation.The provided information states the device was tested before use, indicating the damage occurred during use.There was no information related to any issues experienced during use, therefore the cause for the deformation could not be conclusively determined.The risk analysis for this failure mode was reviewed, and it was determined that no actions were required.We will continue to monitor 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.

Event Description

There is no new patient or event information to report.

• 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: 10580071
• MDR Text Key: 208342718
• Report Number: 1820334-2020-01750
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)230508(10)13180879
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Catalogue Number: NGE-017115
• Device Lot Number: 13180879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1