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

Catalog Number NTSE-022115-UDH

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that prior to an unknown procedure, the joint of a ncircle tipless stone extractor between the basket and the yellow handle was damaged in some way.Another new device was used to complete the procedure.This occurred before patient contact and no adverse effects to the patient were reported due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.It was reported on (b)(6) 2020 of an incident involving a ncircle tipless stone extractor ntse-022115-udh.The device reportedly was found to have a damaged handle before use on (b)(6) 2020.Further communication with the user facility clarified that the procedure was completed with another device.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, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned for investigation.Visual inspection of the returned device noted the device was returned with the handle and basket formation in the open position.The mlla (male luer lock adapter) was loose, and the collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.There were kinks in the basket sheath at 30.5cm, 91cm, and 110cm from the distal tip of the basket sheath.The basket sheath accordioned/buckled at the distal end of the support sheath.With the handle in the open position, there was 1cm of coil protruding from the distal end of the basket sheath.Function testing determined the handle does not actuate the basket formation.The handle was disassembled.Further examination noted the support sheath was bent 1cm from the flare of the support sheath.The cannulated handle was severed from the coil assembly.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other complaints associated with the complaint device lot.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 open and could not be close due to sheath damage.The basket sheath was buckled near the handle and kinked in multiple locations along its length.The cannulated handle was also separated from the basket coil assembly.The cause for the sheath damage 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.It is also possible that the device was damaged during shipping, or when loading the device into the device tray.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.

Event Description

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

• 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: 9910014
• MDR Text Key: 198097005
• Report Number: 1820334-2020-00727
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)221009(10)10070850
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 10070850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1