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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

E1- customer (person): street address: (b)(6) // phone number: (b)(6) g4- 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.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 or that a death or serious injury occurred; nor is it admission 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

It was reported that the basket of a ncircle tipless stone extractor was difficult to open during an unknown procedure.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

H3: device evaluated by mfg.= other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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

Additional information received on 20sep2023: the device was not tested and there was not any damage observed prior to use.There was not any difficulty noted when removing the device from the protective hoop.The procedure was completed with another basket.The patient did not experience any adverse effects as a result of the issue.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation evaluation: it was reported that the basket of a circle tipless stone extractor was difficult to open during an unknown procedure.The device was not tested, and there was not any damage observed prior to use.There was not any difficulty noted when removing the device from the protective hoop.The procedure was completed with another basket.The patient did not experience any adverse effects as a result of the issue.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual examination and functional test of the returned device, were conducted during the investigation.The complainant returned one circle tipless stone extractor in the original pouch.The returned device was found to have a basket that was not functional due to sheath damage.The blue basket sheath had pulled free from the handle.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu did not provide any information related to the reported issue.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded the cause for the damaged sheath could not be established.The information provided by the user stated that there was not any damage observed prior to use, indicating the damage occurred during use.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17599342
• MDR Text Key: 321721744
• Report Number: 1820334-2023-01136
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002175201
• UDI-Public: (01)10827002175201(17)250412(10)14662268
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 14662268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1