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

Catalog Number NGE-022115-MB

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 flexible ureteroscopy (urs), using an ngage nitinol stone extractor, while attempting to remove stone fragments from the kidney, the head of the stone extractor fell off and they couldn't use it.The separated section of the device was retrieved from the patient using a "grasper".A new, same type device was opened and the procedure was successfully completed.It was reported there was an injury, but no details about the injury was provided.Additional information was requested regarding the alleged injury and a response was received advising no additional details could be provided.No section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.No additional patient consequences were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: cook was informed of an incident involving a ngage nitinol stone extractor.The basket of the device reportedly separated from the device during a flexible ureteroscopy (urs) procedure.Further communication from the user facility stated that ¿the head of the stone extractor fall of and they couldn't use it.Had to open a new one to finish the operation.Nge-022115-mb.There was injury and product has to be replaced.¿ also: ¿flexible urs was performed, they wanted to take out the stone fragments from the kidney, then the head of the extractor was coming down, so it had to be replaced.Luckily, they had another ngage from this size which worked properly, so they could continue and finish the procedure with success.¿ per the customer no details on the reported patient injury could be provided.Part of the device separated and they took it out with a grasper.The customer did follow up that there had been a mistake and no portion of the device had separated in this case.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, the instructions for use, manufacturing instructions, and quality control data.The device was returned with the handle in the closed position and the basket formation was retracted into the basket sheath.The basket sheath and distal shrink tube was accordioned at the distal tip for approximately 7mm.The mlla (male luer lock adapter) was tight, but the collet knob was loose.The polyethylene terephthalate tubing [pett] measured 3.4 cm in length.Function test determined the handle does not actuate the basket formation.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.A review of complaint history records shows no other complaints associated with the complaint device lot.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.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 basket that was closed and could not be opened due to sheath damage.No part of the device was found to be separated as reported.The customer was contacted again and it was confirmed that no part of the device separated and in fact there was no material that needed to be removed from the patient.The clear outer sheath of the device had moved proximally and was covering the distal end of the basket, preventing it from opening.The clear outer sheath covering the basket misled the user into believing that the basket had separated.Possible causes: the clear outer sheath was not shrunk down over the basket sheath properly during assembly; the distal end of the device caught or rubbed against an unknown object, or; a combination of both.There was not enough evidence to make a conclusive determination of which of the 3 possible causes was likely.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.

Event Description

As per the preliminary device failure investigation on 02nov2020, there was no separation of the device extractor head noted.Rather, the basket formation retracted into the sheath and did not open again.Additional information was also received on 18nov2020 that confirmed this.The doctor confirmed that no portion of the device needed to be removed.He just did not initially know where the device tip went since the basket failed to open back up.The nurse also assumed it broke since it just would not open.

• 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: 10654983
• MDR Text Key: 210585855
• Report Number: 1820334-2020-01832
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482965
• UDI-Public: (01)10827002482965(17)230217(10)10332154
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 10332154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXOR ACCESS SHEATH; OLYMPUS FLEXIBLE URETEROSCOPE; FLEXOR ACCESS SHEATH; OLYMPUS FLEXIBLE URETEROSCOPE
• Patient Outcome(s): Required Intervention