MAUDE Adverse Event Report: COOK INC N-COMPASS NITINOL STONE EXTRACTOR; LQR DISLODGER, STONE BILIARY

Model Number N/A

Device Problems Material Separation (1562); Mechanical Jam (2983)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  Injury  

Event Description

It was reported that the basket of an n-compass nitinol stone extractor became lodged during a stone extraction procedure and was unable to continue functioning.Upon removal, the device was dismantled to make sure that no unintended section of the device was left in the patient.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Customer (person): postal code: (b)(6).Report source (other): (b)(6).Pma/510(k) #: k173009.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.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, d10 correction: b1, b2.H1.H6 - annex e & annex f.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.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

In additional information received on 11feb2022, it was reported that the patient required an additional procedure as a result of this occurrence.It was noted by the sales representative that the, "patient was opened to check if all device pieces were not left behind.".

Manufacturer Narrative

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.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

Additional information was provided on 15feb2022.The procedure being performed was a laparoscopic cholecystectomy.The device was being used to remove gall stones that measured roughly 2- 3 mm.The failure occurred before grabbing the stones, tested on outside working fine, then on entry once they tried to open it had become wedged in the mechanism.It is unknown if the user pulled on the sheath while advancing or retracting the basket.The procedure was completed by acquiring a second identical piece of kit which then worked perfectly.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information - h6 : med device problem code.Investigation ¿ evaluation.(b)(6) hospital nhs trust in the united kingdom informed cook of an issue with a c-ntse-2.4-115-nc3 (n-compass nitinol stone extractor) from lot 13921574.The customer stated the basket portion became lodged inside its own mechanism during a procedure, and did not function.The procedure was completed with a replacement device.The patient required a surgical cutdown to ensure that no device pieces were left behind.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.Reviewed of the device master record (dmr) concluded there are sufficient controls in place to detect failure prior to distribution.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot records no nonconformances.A database search found no additional complaints for lot 13921574.Cook did not identify any nonconforming material in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: ¿warnings this device is designed for the removal of stones and debris no larger than 0.8 cm in diameter.Precautions: pulling on the sheath while advancing or retracting the basket may damage the device, rendering it inoperable.Instructions for use: remove the stone extractor from its outer package and move the thumb tab on the handle to the ¿close¿ position to close the basket.Insert the stone extractor either through the working channel of the choledochoscope or a lumen of an ancillary device used to access the bile duct (for example, a cholangiography catheter or dilation balloon with a working channel of 2.4 french or greater).Note: the provided tuohy-borst adapter, featuring a distal luer lock connector, may be attached to the proximal end of the ancillary device prior to the insertion of the stone extractor, if desired.Advance the stone extractor into the duct and position the distal end beyond the stone or debris.Note: under fluoroscopic monitoring, the tip of the tipped stone extractor (c-ntse-2.4-115-nc3) may be visualized.After confirming that the extractor is positioned alongside or beyond the stone/debris, open the basket by sliding the thumb tab to the ¿open¿ position.Maneuver and manipulate the open basket to capture the stone or debris.Once captured, slowly transition the thumb tab toward the ¿close¿ position to secure the stone or debris maintain pressure on the thumb tab of the handle to hold the stone or debris in place.Slowly retract the stone extractor and the ancillary device (or scope if utilized) together to facilitate the immediate removal of object from the tract.Note: the provided tuohy-borst adapter may be tightened once the stone is captured to secure the position of the stone extractor during removal.This adapter will not lock the basket on the stone or debris, but will secure the position of the sheath relative to the ancillary device.Note: do not use excessive force on the handle.Doing so may result in damage to the device, including but not limited to, basket separation or inability to open/close device.How supplied supplied sterilized by (b)(4) in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the device master record, product labeling, and device history record, there is so indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.The customer stated basket portion became lodged inside its own mechanism.Based on the information that the patient required an additional procedure to check for device fragments, it is possible that the device separated.It is unknown if the user pulled on the sheath while advancing or retracting the basket.The ifu recommends not pulling on the sheath during advancement or retraction to avoid damage to the basket.There is no evidence of manufacturing deficiency.Cook concluded the cause of event could not be established.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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

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

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Type of Device: LQR DISLODGER, STONE BILIARY
• 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: 13505148
• MDR Text Key: 296076759
• Report Number: 1820334-2022-00190
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002362502
• UDI-Public: (01)10827002362502(17)240328(10)13921574
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: N/A
• Device Catalogue Number: C-NTSE-2.4-115-NC3
• Device Lot Number: 13921574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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
• Treatment: OLYMPUS SCOPE
• Patient Outcome(s): Required Intervention