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

Model Number G17520

Device Problem Break (1069)

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

Event Date 12/08/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: name and address: phone: (b)(6).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, prior to an unknown procedure using a ncircle tipless stone extractor, the basket was broken.Upon removing from the package, the basket was discovered to already be broken.It is unknown how the procedure was completed.No adverse effects have been reported due to the alleged malfunction.

Manufacturer Narrative

Investigation ¿ evaluation.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, drawings, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.Inspection of the returned device noted the device was returned with the handle and the basket formation in the open positions.The mlla (male luer lock adapter) and collet knob were both tight.One basket wire was found to have been pulled out of the distal cannula.Dried residue was observed on the basket, indicating the device was used.Functional testing of the device determined that the handle could 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.The returned device was found to have had one of the basket wires pulled free from the basket cannula.Dried residue was observed on the basket, indicating the device was used, contradicting the reported information that the issue was discovered before use.Based on the investigation of the device, it appears most likely the wire of the basket were broken during use.It is likely the wire was caught on another device being used during the procedure, and excessive force was applied, causing the basket wires to break.The ifu contains a caution not to apply excessive force during use, or the damage to the device may occur.Cook has concluded that the most likely cause of this malfunction is unintended use error.Per the quality engineering risk assessment, no further action is warranted.We 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

No additional patient or event information has been received since the last report was submitted.

• 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: 9537628
• MDR Text Key: 178331686
• Report Number: 1820334-2020-00002
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002175204
• UDI-Public: (01)00827002175204(17)220307(10)9574723
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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 Expiration Date: 03/07/2022
• Device Model Number: G17520
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 9574723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 64