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

Catalog Number NGE-022115-MB

Device Problem Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k) #: 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 ureteral holmium laser lithotripsy, the basket of an ngage nitinol stone extractor would not open when the device was inserted under an endoscope.The device was removed and replaced with another 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.

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: as reported, during a ureteral holmium laser lithotripsy, the basket of an ngage nitinol stone extractor would not open when the device was inserted under an endoscope.The user disassembled the handle of the device in an attempt to use it after the basket would not open.The device was not tested before use.The device was removed and replaced with another 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.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 was tight, and the collet knob was tight and secure.Approximately 1.2cm of the cannulated handle protruded the collet knob.The support sheath was slightly bowed.A function test determined the handle did not actuate basket formation.The handle was disassembled.The cannulated handle was severely kinked 11.7cm and 12.9cm from the proximal end.The basket formation could not be manually actuated.Adhesive was noted on the distal end of the support sheath.A document-based investigation evaluation was performed.No related nonconformances were recorded, and no additional 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 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 provided with instructions for use which caution, ¿enclose the device in the sheath before removing from the tray/holder,¿ and, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ since the device was disassembled by the user, it could not be determined if the damage occurred before or after the device was disassembled.The basket formation could not be manually actuated when tested, but a video provided by the user shows the basket functioning manually after the handle was disassembled by the user, which indicates the device likely experienced damage after the user disassembled the device.Based on the available information, cook has concluded that a cause for the failure of the basket to open could not be determined.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.

Event Description

Additional information received 19jan2021.The user disassembled the handle of the device in an attempt to use it after the basket would not open.The device was not tested before use.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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: 11179440
• MDR Text Key: 245978061
• Report Number: 1820334-2021-00102
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482965
• UDI-Public: (01)10827002482965(17)230817(10)13373237
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2021

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: 08/17/2023
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 13373237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 03/01/2021
• Supplement Dates FDA Received: 02/12/2021; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR