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

Catalog Number C-NTSE-2.4-115-NCT4

Device Problems Material Fragmentation (1261); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported the "tip" of the basket of a n-compass nitinol stone extractor was found to be missing upon opening of the product.The device was to be used in a laparoscopy combined with choledochoscopic lithotomy procedure.A translation of the initial report stated that "the front end of the net basket does not have that head".Consequently, the device was not used on the patient.Another device of the same rpn was used to finish the procedure.No adverse effects were reported.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: guangzhou hengkang trade co., ltd.Informed cook on 11dec2020 of an incident involving a n-compass nitinol stone extractor c-ntse-2.4-115-nct4 from lot # 9567374.The device reportedly was found to be missing the tip of the basket before use during a laparoscopy combined with choledochoscopic lithotomy procedure on (b)(6) 2020.Another device was used to complete the procedure.The patient reportedly experienced no harm as aa result of the issue.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.The complaint device was returned for evaluation.The device was returned with the handle and basket formation in the closed positions.The male luer lock adapter and collet knob were tight and secure.A visual exam noted no kinks in the basket sheath, however, there were several broken wires with visible charring in the basket formation.A functional test determined the handle actuates the basket formation.Cook has concluded that the device was manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.The product specification for the complaint device was reviewed and all extractors are 100% inspected for damage and verified to assure the basket opens and closes properly.A review of the device history record and a lot history search found no relevant nonconformances or additional complaints related to this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: "precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur." based on the information provided, inspection and testing of the returned product, and the results of the investigation, a definitive cause for failure was not established.The appropriate personnel have been notified.Per the quality engineering 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.

• 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
• MDR Report Key: 11040612
• MDR Text Key: 223800526
• Report Number: 1820334-2020-02339
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002362519
• UDI-Public: (01)10827002362519(17)211112(10)9567374
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Catalogue Number: C-NTSE-2.4-115-NCT4
• Device Lot Number: 9567374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1