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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/08/2018

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 the user opened the package for the ncircle tipless stone extractor and found that the basket would not open or close.Another 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, drawings, instructions for use, quality control data, and specifications.One device was returned for investigation.The device was returned with the handle and the basket formation in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is finger tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length.A visual examination noted the support sheath is bowed in appearance.The distal tip is smashed starting at the distal tip and extending 3 mm.There were four kinks noted in the basket sheath located at the following locations: 53 cm from the distal tip, 87.8 cm from the distal tip, 91.5 cm from the distal tip, and 103.5 cm from the distal tip.A functional test determined the handle actuated the basket formation to the open and closed positions.Although the reporter advised they were unsure of the actual device lot, lot number 8547590 was provided as the possible lot associated with this complaint report.Therefore, lot number 8547590 was reviewed as a part of this investigation.A review of the device history record found no non-conformances associated with the provided device lot.A complaint history search revealed this is the only complaint associated with lot number 8547590.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 a basket that would open and close, but the sheath was also found to be damaged in multiple locations.The sheath damage makes it possible the device would not function when in the tortuous path inside the scope during use.This also matches the provided information that the device functioned before use, but not during use.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use 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.

Event Description

During the transureteral lithotripsy (tul) procedure in the kidney, the ncircle tipless stone extractor would not open/close smoothly when checking the device function during preparation.However, the doctor used it on a patient because the basket could open/close anyway.The basket became unable to open/close during use after performing stone extraction one or two times.Therefore, another ntse-015115(lot unknown) was used instead.There have been no adverse effects to the patient reported.

Manufacturer Narrative

Corrected data: patient code.

• 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: 7526721
• MDR Text Key: 108729820
• Report Number: 1820334-2018-01531
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1