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

Catalog Number NGE-022115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

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 a ureteroscopy with stone removal procedure, using a ngage nitinol stone extractor, the basket would not open or close properly.The device was placed down an olympus p4 scope and when attempting to open the basket around the stone, the basket was stiff/resistant to open.The stone was grabbed, but the basket was stiff/resistant to close.The device was removed from the patient and the basket would not open to release the stone.Another same type device was used to retrieve the remaining stones with no further complications.The patient did not require any additional procedures due to this occurrence.No adverse events have been reported as a result of the alleged malfunction.

Event Description

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

Manufacturer Narrative

Event summary: it was reported, during a ureteroscopy with stone removal procedure, using a ngage nitinol stone extractor, the basket would not open or close properly.The device was placed down an olympus p4 scope and when attempting to open the basket around the stone, the basket was stiff/resistant to open.The stone was grabbed, but the basket was stiff/resistant to close.The device was removed from the patient and the basket would not open to release the stone.Another same type device was used to retrieve the remaining stones with no further complications.The patient did not require any additional procedures due to this occurrence.No adverse events have been reported as a result of the alleged malfunction.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One ngage nitinol stone extractor was returned for investigation with the handle in the open position and the basket formation in the closed position.The male luer lock adapter (mlla) was tight, and the collet knob was tight and secure.The support sheath was slightly bowed.Kinks were noted in the basket sheath 6mm from the nose of the mlla and 46.5cm from the distal tip.The handle did not actuate the basket formation.During attempted actuation, the basket sheath bent at the kink near the mlla; the braiding on the basket sheath had severed at this kink.A document-based investigation evaluation was also performed.No related non-conformances were recorded, and no other lot-related complaints have been received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions which state, ¿excessive force could damage device.¿ the returned device was found to have a basket that was closed and could not be opened due to sheath damage.The basket sheath was kinked in multiple locations an was severed near the yellow support sheath.The sheath damage was preventing the basket from functioning.The sheath may have been inadvertently damaged during use, but no information related to handling damage was known, so the cause could not be confirmed.Cook will continue 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 10926956
• MDR Text Key: 219318819
• Report Number: 1820334-2020-02200
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)230914(10)13426446
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: NGE-022115
• Device Lot Number: 13426446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS P4- DIGITAL FLEXIBLE URETERSCOPE