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

Model Number G18778

Device Problem Break (1069)

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

Event Date 03/22/2019

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 during a ureteroscopy of the left distal ureter to remove a stone using an unspecified and a ncircle tipless stone extractor, the tip of the ncircle tipless stone extractor basket broke when exiting the scope.It is reported that the patient weighed "(b)(6)" it is not specified whether it is pounds or kgs.No section of the device remained inside the patient's body.The patient did not require any additional procedures as a result of the difficulty.No adverse events have been reported as a result of the alleged malfunction.

Event Description

The handle was pointed towards the patient¿s body, and the device was tested.It was noted to be uncoiled prior to putting it into the wolf uretereroscope (channel size unknown).By using a replacement basket the case was completed with no adverse effects.The stone was approximately 4-5 mm in size.

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.The device was returned with the handle in the open position.The basket formation is severed from the coil assembly.The coil assembly was returned with only the coil.The severed basket formation has a broken wire 3 mm from the distal cannula.Two wires are extending from the proximal end of distal cannula of the severed basket formation.There is a kink in the basket sheath 44.5 cm from the distal tip.Functional testing determined the handle does not actuate.Visual examination noted discoloration on the wires, which indicates the device may have been cut by a laser.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history revealed no additional complaints associated with the complaint device lot.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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The returned device was found to have the basket assembly separated from the rest of the device.The two wires that connect the basket assembly to the handle were broken proximal of the basket cannula.The ends of the broken wires are necked in appearance, indicating the wires broke from an applied tensile load.One of the four basket wires is broken.The ends of the broken basket wire were discolored and had a melted appearance, indicating exposure to a laser.The sheath of the basket was kinked approximately midway along its length.The provided information states the basket of the device broke when exiting the scope.A 4-5 mm stone was being removed.The size of the working channel of the scope was unknown.It is likely the size of the stone was larger than the working channel of the scope, causing the stone to be stuck inside the scope and subsequently breaking the wires when force was applied while attempting to remove the stone from the scope.All devices undergo a pull test of the basket assembly during manufacturing.The broken basket wire was not mentioned in the provided information.The discolored and melted appearance of the ends of the basket wires indicate the wire was broken due to exposure to a laser.It could not be determined if this occurred before the basket was stuck inside the scope, or occurred after being removed from the scope.The sheath was found to be kinked.The kinking could have occurred anytime during the procedure, or during return shipping of the device.Based on the available information, the most likely cause for the basket separating from the device is that the stone being removed was too large for the working channel of the scope and the wires broke during the attempt to pull the stone through the scope.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: 8482776
• MDR Text Key: 140946087
• Report Number: 1820334-2019-00771
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)211217(10)9388127
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: G18778
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 9388127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 64