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

Catalog Number NTSE-022115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: other non-healthcare professional: coordinator.Pma/510k # exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that prior to an unknown procedure, a ncircle tipless stone extractor was removed from the packaging and found to not open and close as intended.The product dud not make patient contact.It is currently unknown how the procedure was completed.No adverse effects to the patient have been reported due to this incident.Additional patient and event information has been requested.At this time, all known information is included.A follow up report will be submitted if additional details requested are received.

Event Description

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

Manufacturer Narrative

Investigation - evaluation.Cook was informed on 02/11/2020 of an incident involving a ncircle tipless stone extractor.The device reportedly closed but would not open again before use on 02/03/2020.The patient reportedly experienced no additional harm as a result of the issue.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 complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record (dhr) 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.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.Three attempts to obtain the complaint device have been performed.No product returned.No photos provided.A search of the north american distribution center (nadc) database found all devices from the complaint device lot have been shipped.No similar product from the same lot is available for investigation.The complaint device was not returned.There are multiple possible causes for the reported issue that the basket would not open.Without the device available for investigation, the cause could not be 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.

Event Description

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

Manufacturer Narrative

A visual inspection and functional testing of the returned device was conducted.One ncircle tipless stone extractor was returned for investigation.The device was returned with the handle and the basket formation in the closed position.The mlla (male luer lock adapter) was finger tight, and the collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.7 cm in length.The basket sheath had a few waves but no significant kinks.The metal collet was stuck in the udh handle, and the cannulated handle would not come out of the metal collet.The basket sheath was smashed 1.2cm from the distal tip.The returned device was found to have a basket that was closed and could not be opened.Motion of the handle could only move the basket distally a few millimeters.The cannulated handle that comprises the proximal end of the basket assembly was stuck inside the handle and was preventing the basket from opening.The cause for the issue could not be 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 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: 9749788
• MDR Text Key: 180771127
• Report Number: 1820334-2020-00448
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)220913(10)10010533
• 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,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2022
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 10010533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1