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

Catalog Number NTSE-015115

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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 the handle came apart on a ncircle tipless stone extractor while removing a stone during a laser lithotripsy/ureteroscopy.An alternative device was used with no issues to successfully complete the procedure.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Evaluation / investigation: a visual inspection of the returned device was conducted.A review of complaint history, the device history record, drawings, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.A visual examination of the returned device noted the support sheath and the basket sheath are detached.The support sheath is separated 1 mm from the nose of the male luer lock adaptor (mlla).The device was returned with the handle in the closed position.The collet knob and mlla are tight.The polyethylene terephthalate tubing (pett) measures 2.8 cm in length.The points of separation have the appearance of being stretched and pulled to separation.The coil assembly is bent 2.1 cm from the distal tip of the support sheath in two locations.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history for this device lot revealed one additional complaint associated with lot number 8526118.The second complaint came from the same customer and was for the same issue.As 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.The complaint device was found to have damage and separated components.Based on the investigation of the returned device, it appears the device was damaged near the handle, causing the bent handle, cannula, and damage to the support tube and sheath.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling of the device.Per the quality engineering risk assessment, no further action is warranted.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: 7376888
• MDR Text Key: 103797017
• Report Number: 1820334-2018-00822
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)210122(10)8526118
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR