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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).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

It was reported that the user opened the package for the ncircle tipless stone extractor and checked device function, but the basket would not open or close.Another ncircle tipless stone extractor was used to complete the procedure.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

Manufacturer Narrative

Medical device: lot number provided.Device available for evaluation: device returned.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Investigation, evaluation: visual inspection and functional testing of the returned device was conducted during the investigation.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the collet knob and collet detached from the handle.There is approximately 2.5 cm of the cannulated handle protruding from the udh handle, and the cannula is bent.The polyethylene terephthalate tubing (pett) was not returned.The male luer lock adaptor (mlla) is loose.A visual examination noted the support sheath is severed 1.5 cm from the mlla.The first segment of the support sheath is still adhered to the basket sheath, but, the second segment of support sheath is detached from the basket sheath.There were no kinks noted in the basket sheath.A functional test determined the handle does not actuate the basket formation.The device history records were reviewed and found no non-conformances related to the reported failure.A review of complaint history revealed this complaint is the only one associated with the complaint device lot number.The instructions for use (ifu) provides the following in the precautions section: enclose the device in the sheath before removing from the tray/holder.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.Devices are inspected for damage and functionality prior to packaging.The complaint device was found to have been disassembled prior to receiving it for evaluation.Based on the investigation, it appears most likely the device basket did not function due to damage to the cannulated handle and a separated support sheath.The cannulated handle was likely bent due to side forces being applied to the sheath of the device with the basket in the open position.When the basket is in the open position, part of the cannulated handle is located in the proximal section of the sheath and it can become damaged if the sheath is bent.The returned device was found to have sheath damage in the support sheath area (proximal end).The observed damage likely occurred during handling/use of the device.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and 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: 7469478
• MDR Text Key: 106875726
• Report Number: 1820334-2018-01292
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1