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

Catalog Number NCT4-024115

Device Problem Difficult to Open or Close (2921)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

E1: customer name and address = line 2: (b)(6).G4: 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.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

As reported, the basket of the 'ncompass nitinol tipless stone extractor' cannot be opened prior to an unknown procedure.While testing the device, the user found handle was "relatively blocked", the head could not be opened, and confirmed that the basket could not function normally.This observation was made prior to patient contact.The procedure was completed with a new device.Additional information regarding event details has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 30aug2023.Corrections: h6 (annex e, f, g).Summary of event: as reported, the basket of the 'ncompass nitinol tipless stone extractor' cannot be opened prior to an unknown procedure.While testing the device, the user found the handle was "relatively blocked", the head could not be opened, and confirmed that the basket could not function normally.This observation was made prior to patient contact.The procedure was completed with a new device.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found one potentially related non-conformance related to the complaint issue reported for lot 15243640.All devices are inspected for functionality and damage during manufacturing and quality control checks and the complaint device had passed those inspections.The possibly related non-conformance was not sufficient evidence to suspect other devices in the lot could have been non-conforming.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device for lot 15243640.Because adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there was no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The ifu [t _ ntse_ rev1; 'ncircle, ncompass, and nforce stone extractors'] did not provide any information related to the reported issue.Functional tests and visual inspection of the returned complaint device were also conducted.One unused 'ncompass nitinol tipless stone extractor' was returned for investigation.The basket was returned closed and was unable to be opened upon functional testing.The device was then disassembled and it was found that the basket assembly was kinked and twisted at the cannulated handle.The complaint was confirmed based on the device failure analysis.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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.

Event Description

Additional information received 30aug2023: the patient did not experience any adverse effects 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: 17337376
• MDR Text Key: 319687044
• Report Number: 1820334-2023-00921
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002327013
• UDI-Public: (01)10827002327013(17)260227(10)15243640
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 15243640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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