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 05/30/2023

Event Type  malfunction  

Event Description

It was reported that prior to patient contact for unspecified procedure the user found that the basket of an ncompass nitinol tipless stone extractor was "stuck" and was unable to be extended.The user changed to an unspecified same type device to complete the procedure.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

E3 - occupation: agent.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.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 received 10aug2023: the patient did not experience any adverse effects as a result of the device issue.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 10aug2023.Corrections: h6 = annex e, annex f.Summary of event: a representative of shanghai hongfan trading co.(g p) reported on 30may2023 that there was an incident with an ncompass nitinol tipless stone extractor (rpn: nct4-024115, lot number 15130815).It was reported that, prior to patient contact for an unspecified procedure, the user found that the basket was "stuck" and was unable to be extended.The user changed to an unspecified same type device to complete the procedure.The patient did not experience any adverse effects as a result of the device issue.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 no related non-conformances reported for lot 15130815.A complaint history database search showed no other related complaints associated with the complaint device lot 15130815.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 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 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 'ncompass nitinol tipless stone extractor' was returned for investigation.The fittings on the handle were tightened; the actuator on the handle would not move when the device was tested; the cannulated handle is bent approximately 14.3cm from distal tip; the handle was disassembled and it was not possible to actuate basket formation manually.The evidence from the complaint file, device history record, complaint history and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The returned extractor confirmed the customer complaint, when tested the basket would not open when tested.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.

• 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: 17117911
• MDR Text Key: 317077594
• Report Number: 1820334-2023-00724
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002327013
• UDI-Public: (01)10827002327013(17)251219(10)15130815
• 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
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• 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: 15130815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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