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

Catalog Number NTSE-030115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: other non-healthcare professional: professor.Pma/510k # exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that prior to a rigid ureteroscopy procedure a ncircle tipless stone extractor was tested and found to not open and close properly.There was no patient contact.It is unknown how the procedure was completed.No adverse effects to the patient have been reported.Additional patient and event details have been requested.A follow up report will be submitted when additional information is received.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.Corrected information: d5.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

Additional information received on 10feb2020: the procedure was completed by using another ntse-030115-udh which was working prior to use and during the procedure.The customer might have attempted to disassemble the complaint device, but the problem was that the outer sheath moved instead of the basket formation when the handle was actuated.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Investigation ¿ evaluation: cook was informed on 02/04/2020 of an incident involving a ncircle tipless stone extractor (ntse-030115-udh).The device reportedly had a basket that would not open and close before use during a rigid urs procedure on (b)(6) 2020.Another ntse-030115-udh device was used to complete the procedure.The patient reportedly experienced no additional harm as a result of the issue.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, the instructions for use, drawing, manufacturing instructions, specifications, and quality control data.One ncircle tipless stone extractor was returned for investigation.Visual inspection of the returned device noted the handle was in the closed position, and the basket formation was in the open position.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.6 cm in length.There were no kinks in the basket sheath.The basket formation does not retract into the basket sheath when the handle was actuated.When the handle is in the open position, 2cm of the coil assembly was exposed.Functional testing determined the handle actuated the coil assembly.The handles was disassembled.Further visual examination noted the support sheath and basket sheath were detached.There was minimal glue on the basket sheath.The basket formation could be manually activated.A review of the device history record (dhr) 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 are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a basket that was opened and could not be closed.The basket sheath and blue support sheath were separated.The two sheaths are glued together during manufacturing.Glue residue was found on the basket sheath, indicating proper manufacturing.The cause for the separated sheaths could not be determined.The provided information stated the issue occurred before patient contact.It is possible the device was damaged during unpacking and/or subsequent handling.There is not enough evidence to make a conclusion as to the cause of the damage.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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: 9682662
• MDR Text Key: 178198533
• Report Number: 1820334-2020-00310
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002176277
• UDI-Public: (01)10827002176277(17)211009(10)9221044
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Catalogue Number: NTSE-030115-UDH
• Device Lot Number: 9221044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1