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

Catalog Number NTSE-045065-UDH

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/02/2022

Event Type  malfunction  

Event Description

It was reported that the user opened the packaging to a ncircle tipless stone extractor and found the inner packaging was opened/unsealed.The procedure was completed using another new device.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.

Manufacturer Narrative

Customer phone: (b)(6).Occupation: non-healthcare professional - unknown.Pma/510(k) number: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: it was reported that the user opened the packaging to a ncircle tipless stone extractor and found the inner packaging was opened/unsealed.The procedure was completed using another new device.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 were conducted during the investigation.Due to the ongoing covid-19 lockdowns in china, the returning device does not have an estimated date of shipment.If the device is received in the future, the file will be updated.A photo of the complaint device was provided showing that the chevron end of the pouch was opened.The imprint of the seal on the clear mylar layer of the pouch could be seen and was free from wrinkles, clear areas, and burnt seals.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents was conducted.All ntse packaging seals are inspected during quality control checks.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: ¿how supplied¿: ¿supplied sterile by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use product if there is a doubt as to whether the product is sterile.[¿] upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the visual evidence provided in user photos, the most likely cause of the reported failure is that the pouch was inadvertently opened.However, based upon the available information and results of the investigation, cook has concluded that the cause of the opened pouch could not be conclusively determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.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

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

• Brand Name: NCIRCLE TIPLESS 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: 14142266
• MDR Text Key: 289661557
• Report Number: 1820334-2022-00613
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002175201
• UDI-Public: (01)10827002175201(17)240728(10)14116609
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 14116609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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