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

Catalog Number NTSE-022115-UDH

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(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 during a flexible ureteroscopy, the doctor pulled the ncircle tipless stone extractor to extract stones but a wire was detached prior to using.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

Investigation ¿ evaluation.Visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.The device was returned with the handle between the open and closed position.The basket formation was partially opened when returned.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose with 5 threads exposed.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A visual examination noted the support sheath is bowed in appearance.A kink was noted in the basket sheath 86 cm from the distal tip.A functional test determined the handle actuated the basket formation.One of the basket wires was found to be broken; the other three wires are secure, but, asymmetrical in appearance.A review of the device history record found no non-conformance related to the reported failure.A complaint history search revealed no other complaint associated with complaint lot number 8396772.Per the instructions for use (ifu) precaution 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.Measures have been initiated to address this failure mode.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.Investigation ¿ evaluation.Visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.The device was returned with the handle between the open and closed position.The basket formation was partially opened when returned.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose with 5 threads exposed.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A visual examination noted the support sheath is bowed in appearance.A kink was noted in the basket sheath 86 cm from the distal tip.A functional test determined the handle actuated the basket formation.One of the basket wires was found to be broken; the other three wires are secure, but, asymmetrical in appearance.A review of the device history record found no non-conformance related to the reported failure.A complaint history search revealed no other complaint associated with complaint lot number 8396772.Per the instructions for use (ifu) precaution 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.Measures have been initiated to address this failure mode.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: 7460282
• MDR Text Key: 106633171
• Report Number: 1820334-2018-01188
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)201127(10)8396772
• 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
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1