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

Catalog Number NTSE-015115

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2020

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 before an unknown procedure, an ncircle tipless stone extractor was opened and the sheath was found to be kinked.Another ncircle tipless stone extractor was opened to complete the procedure.No adverse effects to the patient were reported.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Investigation evaluation.It was reported that before an unknown procedure, an ncircle tipless stone extractor was opened and the sheath was found to be kinked.Another ncircle tipless stone extractor was opened to complete the procedure.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, and quality control data.One device was returned for investigation.Visual inspection of the returned device found that the device was returned with the handle and basket formation in the closed positions.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing (pett) measured 2.8 cm in length.Kinks were noted in the basket sheath 71.5 cm from the distal tip and 110.5 cm from the distal end.Functional testing of the device determined that the handle does not actuate the basket formation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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 lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.Cook could not establish a definitive conclusion for the cause of this complaint.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.

• 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: 9933056
• MDR Text Key: 186722719
• Report Number: 1820334-2020-00773
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)230130(10)10299276
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 10299276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1