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

Catalog Number NTSED-024115-UDH

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a ncircle delta wire tipless stone extractor was being used, and the basket could not open and close properly.The user attempted to open the basket outside of the body but found it difficult to open and close.A new basket was replaced for the procedure.This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Summary of event: as reported, a ncircle delta wire tipless stone extractor was being used, and the basket could not open and close properly.The user attempted to open the basket outside of the body but found it difficult to open and close.A new basket was replaced for the procedure.This occurred prior to patient contact; there was no impact to the patient.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.A visual inspection and a functional test of the returned complaint device was also conducted.The device was returned to cook for investigation in open packaging.The basket was in the open position and all the fittings were right.When attempting to actuate the basket with the handle, the support sheath broke.Friction/resistance was felt between the cannula and the basket sheet and it was not transitioning as it should.There were no kinks or bends observed in the basket sheath.Handle was disassembled to manually operate the basket.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the instructions for use (ifu).The following information is provided to the user 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.The cause for the damage was unknown.Excessive force may have been inadvertently applied to the device, however no information was known regarding device handling, therefore the cause of the issue 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 new patient or event information to report since the previous medwatch report was sent.

• Brand Name: NCIRCLE DELTA WIRE 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: 12810650
• MDR Text Key: 283620821
• Report Number: 1820334-2021-02494
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)240322(10)13837637
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13837637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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