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

Catalog Number NTSED-024115-UDH

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation = non-healthcare professional - assistant nurse manager.Pma/510(k) number = exempt.Device evaluated by mfg = other - unknown if device 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 the clamps of the ncircle delta wire tipless stone extractor were kinked and the device would not close.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event summary it was reported that the clamps of the ncircle delta wire tipless stone extractor were kinked and the device would not close.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.Investigation - evaluation a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The device was not returned for investigation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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 relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control, and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Based on the limited information provided, it was determined the likely issue experienced by the user was that the basket sheath of the two devices kinked/bent, preventing the baskets from closing.The cause for the suspected damage was unknown.Excessive force may have been inadvertently applied to the device, but no information is known regarding device handling, and therefore the cause of the issue could not be conclusively 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 DELTA WIRE 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: 12450688
• MDR Text Key: 270818451
• Report Number: 1820334-2021-02129
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)240430(10)13930258
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13930258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1