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 No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Pma/510k #: exempt this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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

As reported, prior to attempting to remove stones from the kidney/ureter using a ncircle tipless stone extractor, the basket wire broke.Another same type device was used to complete the procedure.No adverse effects were reported due to the alleged malfunction.

Event Description

Additional information received 14dec2020.The device was used for a transurethral lithotomy.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary: as reported, prior to attempting a transurethral lithotomy using a ncircle tipless stone extractor, the basket wire broke.Another same type device was used to complete the procedure.No adverse effects were reported due to the alleged malfunction.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One ncircle tipless stone extractor was returned for investigation with the handle and basket formation in the closed position.The male luer lock adapter (mlla) was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing measured 2.5cm in length.The support sheath was severed at the nose of the mlla.One wire in the basket formation was pulled out of the distal cannula; the other three wires were secure.A document-based investigation evaluation was also performed.No related non-conformances were recorded.One additional complaint was received from this product lot.The two complaint issues were not related, and there is thus no indication of a common issue that could have affected other devices in the lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions which caution, ¿enclose the device in the sheath before removing from the tray/holder,¿ and, ¿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, the cannula that secures the proximal end of the basket wires together.The issue was found during use of the device, which indicates the wire was secured before use.Based on the available information, cook has concluded that possible causes for the separated basket wire include: 1) the basket was assembled incorrectly, without enough glue applied to securely hold the basket wire in place, 2) procedural factors encountered when removing the stone(s) pulled on the basket wire with enough force to pull it free from the basket cannula, or 3) a combination of these two factors.There is not enough information available to determine the likely cause of the issue.It was also observed that the basket sheath was damaged near the handle.The damage was not preventing the basket from functioning.The device was returned in a plastic bag and not the original tray, making it possible the sheath damage occurred during return shipping.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 10942948
• MDR Text Key: 219553498
• Report Number: 1820334-2020-02235
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13343087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 12/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1