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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Postal code: (b)(6).Occupation = unknown.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

It was reported that the basket of the n-circle delta wire tipless stone extractor did not close while in use.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Event Description

Additional information was provided on 18may2021.The malfunction was noted before the device could be used inside of the patient.No part of the device separated.The device was tested prior to use.The procedure was completed by using another stone extractor device.No additional procedures were required due to the occurrence.No adverse effects have been reported due to the occurrence.

Manufacturer Narrative

H3: device evaluated by mfg- other (81) - device evaluation has begun; however, a conclusion is not yet available.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.

Manufacturer Narrative

Event description: as reported, prior to the start of an unspecified procedure, an ncircle delta wire tipless stone extractor was tested and found that the the basket would not close.Another stone extractor device was used to complete the 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 (dhr), manufacturing instructions, the instructions for use (ifu), and quality control data.One ncircle delta wire tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle in the closed position, the basket formation in the open position, and with the cannulated handle out of the collet.The mlla [male luer lock adapter] was loose.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.9 cm in length.The pett was loose in the handle and fell out when the device was removed from the shipping tray.The handle was disassembled.The collet was missing from the handle and not returned.The basket sheath was slightly bowed at the distal tip of the support sheath, the basket formation could be manually actuated.Resistance was noted when manually closing the basket formation.It appeared that the handle was disassembled during use.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 related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that 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 relevant manufacturing and quality control documents was conducted.All extractors are 100% verified to assure the basket opens and closes properly.Cook has concluded that 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.The complaint device was found to have a basket that was open and could not be closed.The handle had been disassembled, preventing the basket from functioning.It is likely the handle was disassembled by the user after the basket failed to close as reported.It was also observed that the basket sheath was bowed at the yellow support sheath.It is likely the sheath damage was preventing normal basket function.The cause for the damage could not be determined.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel have been notified, and we will continue to monitor 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

There is no new patient or event information to report.

• 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: 11854719
• MDR Text Key: 251901800
• Report Number: 1820334-2021-01371
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)240212(10)13756814
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2024
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13756814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1