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

Catalog Number NTSE-022115-UDH

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number- exempt.Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a stone extraction procedure, the basket of an ncircle tipless stone extractor separated.A fragment of the basket was subsequently removed from the patient's bladder.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.Additional information regarding the event has been requested.

Event Description

No new patient or event information since the last report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, an unknown patient required the use of a ncircle tipless stone extractor during a stone removal procedure.The operator reported during the procedure, the basket separated.A fragment of the basket was subsequently removed from the patient¿s bladder.It is unknown if the original procedure was completed successfully.It was reported that the patient did not experience any adverse effects due to this occurrence.Additional procedural questions were requested from customer.However, at the time of this clinical, no additional information has been received.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.The device was returned with the handle in the closed position.The device was returned coiled, tangled, and wrapped in a glove.The mlla (male luer lock adapter) was loose, but the collet knob was tight and secure.Polyethylene terephthalate tubing [pett] measured 2.5 cm in length.The support sheath was bowed.The basket sheath had multiple kinks, most likely from the way it was returned.The basket formation was not attached to the coil assembly and was not returned.A function test determined the handle does not actuate the basket formation.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other 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.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 be missing the basket assembly.The basket assembly had separated from the distal end of the coil assembly.The sheath was also damaged, being kinked and bent in multiple locations.The device was returned in a ziploc bag with the sheath tied with a glove, therefore it was determined the sheath damage was caused after the basket had separated and was not a contributing factor in the basket separation.It is possible that the basket separated due to forces applied to the device during use, which could happen when withdrawing a stone into the scope that was too large.There were no known procedural related issues that occurred during use.Therefore, the cause for the separation could not be determined.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: 11166661
• MDR Text Key: 226778484
• Report Number: 1820334-2021-00089
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)231014(10)13489785
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13489785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention