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

Catalog Number NTSED-024115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #- 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, the basket of an ncircle delta wire tipless stone extractor would not completely open.Additional event and patient information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: d4, h4.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.

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 unknown, unchanged, or unavailable.Additional information: b3.Event summary cook was informed of an incident involving a ncircle delta wire tipless stone extractor.It was reported that the basket would not open fully before use during an unspecified 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, manufacturing instructions, and quality control data.The device was returned with the handle in the closed position and the basket formation in the partially closed position.The mlla (male luer lock adapter) and collet knob were tight and secure.Polyethylene terephthalate tubing [pett] measures approximately 3 cm in length.Approximately 1 cm of closed basket formation was extending the basket sheath with the handle in the closed position.Visual exam notes the basket formation will not fully retract in the basket sheath during handle actuation, and there was a slight bend in the support sheath approximately 3cm from the mlla.There was a kink in the basket sheath approximately 3cm from the distal tip of the support sheath.Functional test determined the handle does actuate the basket formation.The handle was disassembled for further investigation.Visual exam notes the basket formation can be manually actuated, however the knot in the basket formation does not retract into the basket sheath.The handle was reset and reassembled.Additional function test determines after handle reset, the basket formation still does not retract fully into the basket sheath.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 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 a basket that would fully open, but not fully close.Sheath damage was noted, with the yellow support sheath slightly bent and a kink in the basket sheath near the handle.The basket assembly was removed from the handle and it was found the basket still would not close fully.The sheath damage was preventing the basket from closing.The cause for the damage 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 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: 11633195
• MDR Text Key: 266872433
• Report Number: 1820334-2021-01092
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13760199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1