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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation = non-healthcare professional, district manager.Pma/510(k) number = exempt.(b)(4) - customer unsure if product will be returned.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 that one of the four wires of a ncircle tipless stone extractor basket broke.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Additional information: d9, h3.Event summary: cook was informed of an incident involving a ncircle tipless stone extractor from unknown lot.It was reported that one of the four wires of the basket broke during an unknown procedure type on an unknown date.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.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 the instructions for use, manufacturing instructions, and quality control data.The complainant returned one ncircle tipless stone extractor with the lot number unknown.The complainant stated one of the four wires of the basket broke.The device was returned with the handle and the basket formation in the open position.The mlla (male luer lock adapter) was loose, but the collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured approximately 3 cm in length.The basket formation was noted to have a wire pulled out of the distal cannula.The support sheath was severely bowed.The basket sheath was found to be severed near the distal tip of the support sheath.Function test determined that when actuating the handle, the basket sheath moves, but it does not actuate the basket formation.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.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 had 1 of the 4 basket wires pulled free from the basket cannula that secures the proximal end of the basket wires.It was also found that the basket sheath had separated near the yellow support sheath, preventing the basket from functioning.Since the sheath damage was not reported by the user, it was assumed it occurred after the basket wire issue occurred.It is possible that there were procedural factors such as the size, shape, or location of the stone that caused the basket wire to pull free from the cannula, however, there was not enough evidence/information available to conclusively determine the cause of the issue.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.

• 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: 11932672
• MDR Text Key: 255486038
• Report Number: 1820334-2021-01454
• Device Sequence Number: 1
• Product Code: FFL
• 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: 07/26/2021

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 Catalogue Number: NTSE-022115-UDH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1