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

Model Number G18778

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that during a cystourethroscopy laser lithotripsy stone removal, the physician was using a ncircle tipless stone extractor.While attempting to remove the stone one of the wires in the basket broke and "popped out".None of the device detached completely.The physician finished the procedure with the complaint device.No adverse effects to the patient were reported to have occurred due to this occurrence.No unintended section of the device remained inside of the patient's body.

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, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted that device was returned with the handle and the basket formation in the open position.The mlla (male luer lock adapter) was loose, and the collet knob was tight.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.The support sheath was partially severed at the nose of the mlla.There was a kink in the basket sheath located 86cm from the distal tip of the basket sheath.There were also several other bends throughout the basket sheath.One basket wire was pulled out of the distal cannula.Functional testing determined the handle actuated 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 related complaints from the lot 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 1 of the 4 basket wires pulled free from the basket cannula that holds the wires at the proximal end of the basket in place.Damage to the yellow support sheath was also noted, but the damage was not preventing the basket from functioning.The cause for the wire to have pulled free from the basket cannula could not be determined with the available evidence.Possible causes were: manufacturing related issue with the operation of assembling the basket subassembly.Procedural related issue such as the size/shape/location of the stone(s).The basket wire may have been caught on another device.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.

Event Description

No new patient or event information since the last report was submitted on 11nov2019.

• 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: 9305604
• MDR Text Key: 166020568
• Report Number: 1820334-2019-02823
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)220905(10)9992514
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: G18778
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 9992514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1