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

Catalog Number NTSE-022115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

As reported, prior to use in a transurethral lithotomy, the basket of a ncircle tipless stone extractor could not be opened.This was discovered when testing the device before the procedure.The device was replaced with another manufacturer's device to complete the procedure.No adverse effects have been reported to the patient as a result of this occurrence.

Event Description

Additional information was received 20nov2020: the procedure was only extended 1 or 2 minutes.No adverse events occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: b5, d4, h4 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

There is no new patient or event information to report.

Manufacturer Narrative

Event description: as reported, prior to use in a transurethral lithotomy, the basket of a ncircle tipless stone extractor could not be opened.This was discovered when testing the device before the procedure.The device was replaced with another manufacturer's device to complete the procedure.No adverse effects have been reported to the patient as a result of this occurrence.The patient reportedly experienced no harm as a result of the issue.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 tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle between the open and closed position.The basket formation was partially protruding the basket sheath.The mlla [male luer lock adapter] was tight.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.7 cm in length.There were kinks in the basket sheath 9.8 cm from the mlla and again 66.6 cm from the mlla.The support sheath was slightly bowed.A functional test determined the handle actuated the basket formation, but the basket formation did not open completely.The basket formation appeared smashed.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 would not open completely.The basket had a flattened appearance when in the open position.It was also noted that the sheath of the device was damaged, being kinked in two locations and slightly bowed near the handle.The device was returned in a plastic bag, so it is possible, but not confirmed, that the sheath damage occurred during return shipping.The cause of the deformed basket shape could not be conclusively determined.Basket are inspected for proper functioning multiple times during manufacturing and subsequent quality control checks.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.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.

• 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
• MDR Report Key: 10808376
• MDR Text Key: 215280197
• Report Number: 1820334-2020-02052
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13307337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1