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 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number- exempt.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, prior to use during a flexible ureteroscope lithotripsy, the proximal end of the yellow sheath of an ncircle tipless stone extractor was discovered broken.The device did not make patient contact.The patient did not experience any adverse effects due to this occurrence.

Event Description

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

Manufacturer Narrative

Event summary: cook was informed of an incident involving a ncircle tipless stone extractor.The device reportedly had the yellow support sheath break near the handle before use during a flexible ureteroscope lithotripsy procedure.The patient reportedly experienced no harm as a result of the issue.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, and quality control data.The device was returned with the handle and the basket formation in the closed position.The mlla (male luer lock adapter) was loose, but the collet knob was tight secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.The support sheath was severed at the nose of the mlla.Functional testing determined the handle does 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 the 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.The returned device was found to have the yellow support sheath severed at the handle.Although the basket was found to be functional, the sheath damage could have resulted in the basket not opening or closing during use.The device may have been damaged prior to packaging, or during handling after removing from the packaging.There was not enough evidence to make definitive conclusion on where the damage occurred or its cause.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: 10816868
• MDR Text Key: 223761486
• Report Number: 1820334-2020-02062
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)230427(10)13157964
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13157964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 70