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

Catalog Number NGE-022115-MB

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Pma/510(k) #- exempt.Event summary as reported, during a stone extraction procedure, an ngage nitinol stone extractor "broke".A new ngage basket was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.The device was returned for investigation in an opened pouch with the shipping tray.The basket wire was broken, and the support sheath was bent.The handle would not actuate the basket, likely due to the bent support sheath.Under magnification, the ends of the broken wire appeared charred.A document-based investigation evaluation was performed.No related non-conformances were recorded.Two other potentially related complaints have been reported for this lot number, reported under manufacturer report # 1820334-2022-00616 and 1820334-2022-01238.There was not enough evidence to conclude that there was a common cause that would indicate other devices in the lot may have been nonconforming.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.This device is provided with instructions for use which caution, ¿this device is conductive.Avoid contact with any electrified instrument.¿ based on the available information, cook has concluded that unintended user likely contributed to the broken basket wire.The broken wire ends had a charred appearance, indicating exposure to a laser or other electrified instrument, contrary to the precautions of the ifu.Cook will continue monitoring of similar complaints and has 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.

Event Description

As reported, during a stone extraction procedure, an ngage nitinol stone extractor "broke".A new ngage basket was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Upon return evaluation of the device 09sep2022, the basket wire was broken, and the support sheath was bent.The handle would not actuate the basket.The ends of the broken wire appeared charred.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15543862
• MDR Text Key: 306642069
• Report Number: 1820334-2022-01585
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482965
• UDI-Public: (01)10827002482965(17)231117(10)13564342
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

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: Health Professional
• Device Expiration Date: 11/17/2023
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 13564342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male