MAUDE Adverse Event Report: COOK INC NCOMPASS NITINOL 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 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

E1- customer (person): postal code: (b)(6) // phone:(b)(6).E3- occupation: team lead.G4- pma/510(k) #: exempt.H3- no evaluation code desc: it is unknown if device is available for evaluation.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 ncompass nitinol tipless stone extractor could not be opened.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b3 event summary during a flexible ureteroscopy (urs), prior to patient contact, an ncompass nitinol tipless stone extractor was tested in an uncoiled position and the basket would not open.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.Investigation ¿ evaluation a document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection and functional test of the device were conducted.One device returned to cook for evaluation without the packaging, inventory label only.Several bends/kinds were observed along sheath and support sheath; however, the handle did actuate the basket.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.All devices are test functioned during manufacturing and at subsequent quality control inspections.All devices in the lot that were shipped passed the multiple inspections.A review of the dhr for the reported complaint device lot revealed one recorded non-conformance relevant to the failure mode for ¿basket/grasper will not open/close¿ in which eighteen devices were scrapped.A database search did not identify any other events associated with the reported device lot.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.Cook also reviewed product labeling.The product ifu did not provide any information related to the reported issue.A functional test found the basket opened and closed without issue.Complaint confirmed based on customer testimony.It was likely the conditions the device experienced when tested by the user were different that those when tested after device return, resulting in the two different findings.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.¿ per a review of risk documentation, 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.

Manufacturer Narrative

Additional information: b5, d4, d9, e4, h4, h6:health effect - clinical code (annex e) and health effect - impact code (annex f).Corrected information e3, h3 h3: 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.Cook inc.Has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend of (b)(6) 2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on 25nov2023.Per fda-2008-n-0393, questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: ¿¿ if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational.¿ an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.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.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

Additional information was received 02nov2023, the device is available for evaluation.Additional information was received 03nov2023: during a flexible ureteroscopy (urs), prior to patient contact, an ncompass nitinol tipless stone extractor was tested in an uncoiled position and the basket would not open.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.

• Brand Name: NCOMPASS NITINOL 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: 17900421
• MDR Text Key: 325908799
• Report Number: 1820334-2023-01357
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002327013
• UDI-Public: (01)10827002327013(17)260111(10)15159615
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 15159615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/02/2023; 12/08/2023
• Supplement Dates FDA Received: 12/05/2023; 12/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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