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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Name and address: (b)(6).Pma/510(k) #- exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, the basket of an ncircle delta wire tipless stone extractor could not be closed when the handle was actuated prior to an unknown procedure.The basket was eventually closed by the user while attempting to repair it, but the basket then would not open.The device did not make patient contact.Another device was used to complete the procedure.There was no impact to the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, the basket of an ncircle delta wire tipless stone extractor could not be closed when the handle was actuated prior to an unknown procedure.The basket was eventually closed by the user while attempting to repair it, but the basket then would not open.The device did not make patient contact.Another device was used to complete the procedure.There was no impact to the patient.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 (dhr), manufacturing instructions, the instructions for use (ifu), and quality control data.One ncircle delta wire tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle in the open position with the basket formation retracted in the basket sheath.The mlla [male luer lock adapter] was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] was missing.Approximately 1.2 cm of the cannulated handle was protruding from the collet knob.A functional test determined there was resistance when actuating the handle, the basket formation stayed in the basket sheath and would not open.The handle was disassembled during investigation.The cannulated handle was kinked approximately 12 cm and 12.9 cm from the proximal end.The basket formation could not be manually actuated.The distal tip of the support sheath was slightly bent.Adhesive was visible inside the support sheath.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 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 extractors are 100% verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information 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 returned device was found to have a basket that was closed and could not be opened.The condition of the device indicates it was disassembled and reassembled by the user, as stated in the event information.The basket assembly could not be functioned manually when disconnected from the handle.Glue residue was noted inside the support sheath.The glue residue may have affected the ability of the basket to function normally, but a definitive cause could not be established.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel have been notified, and we will continue to monitor 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

There is no new patient or event information to report.

• 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
• MDR Report Key: 11222296
• MDR Text Key: 239078244
• Report Number: 1820334-2021-00146
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)230724(10)13327329
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13327329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1