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

Model Number G18778

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported, prior to a retrograde intrarenal surgery (rirs), a ncircle tipless stone extractor was opened, and it was discovered that a wire in the basket was broken.It is currently unknown how the procedure was completed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The investigation has been completed.The investigation results were included on the last report that was submitted on 19sep2019.The additional information recieved was reviewed, and there were no changes to the investigation results to report.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

Additional information was provided on (b)(6) 2019: the basket was not opened for use.The staff noticed it before the operation.They used a new basket device to complete the procedure.

Event Description

There is no new patient or event information to report.

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 the device was returned with the handle in the closed position and the basket formation in the slightly closed position.The mlla (male luer lock adapter) was tight and the collet knob was tight and secure.A severe bow was noted in the support sheath and the basket sheath was kinked at 54.5 cm and 96.5 cm from the distal tip.There was no discoloration of the basket wires, but one of the basket wires was broken at the knot.Functional testing noted the handle actuates the basket formation.A review of the device history record found 1 non-conformances related to the reported failure mode.One device was scrapped for failing the tensile test that was conducted on all devices from the lot.The remainder of the devices passed the tensile test.The operation of forming the basket wires is manually performed and therefore individual in nature and an issue with 1 devices does not indicate an issue with the other devices in the lot.A review of complaint history records shows no other complaints associated with the complaint device lot.Because 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.The returned device was found to have 1 of the basket wires broken at the distal "knot" of the basket.Damage was noted to the sheath of the device, but the device was returned with the handle outside of the shipping tray, making it likely the damage was caused during return shipping of the device.Additional measures have been conducted to further investigate this failure mode.The investigation determined the cause for the issue was traced to manufacturing.Corrections were identified, but they had not yet been implemented at the time the complaint device was manufactured.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: 8935044
• MDR Text Key: 155701516
• Report Number: 1820334-2019-02127
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)210910(10)9151334
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: G18778
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 9151334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, GUIDEWIRE; ENDOSCOPE, GUIDEWIRE