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

Catalog Number	NTSE-030115-UDH-MB
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # - exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the ncircle tipless stone extractor basket would not open after passing through scope.There has been no adverse consequences to the patient reported.Additional patient and event details have been requested.At the time of this report, no further information has been forthcoming.
Event or Problem Description
No new event information has been received.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.No photograph was provided for review.A search of the north american distribution center (nadc) database shows that all devices from lot 7777819 have been shipped.No similar product from the same lot is available for investigation.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.A review of the device history record for lot # 7777819 found there were no non-conformances related to the reported failure mode.A review of complaint history records revealed one other complaint been associated with device lot number 7777819.The other complaint was reviewed and there was no information that would conclude the two complaints were related.The instructions for use (ifu) states the following in consideration of 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 complaint device was not returned.The provided information states the basket would not open during use.Based on investigation of returned devices that have the same reported issue, the most probable cause for the failure of the basket not to function is sheath damage.There is no information for this complaint that sheath damage occurred, so the definitive cause for the complaint could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8306475
• Report Number: 1820334-2019-00289
• Device Sequence Number: 13467606
• Product Code: FFL
• UDI-Device Identifier: 00827002178724
• UDI-Public: (01)00827002178724(17)200324(10)7777819
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2020
• Device Catalogue Number: NTSE-030115-UDH-MB
• Device Lot Number: 7777819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1