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

Catalog Number NGE-022115

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation = non-healthcare professional - 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 a ngage nitinol stone extractor did not function properly during a ureteroscopy with stone extraction.It is unknown if a section of the device remained inside the patients body.It is unknown if the patient required any additional intervention due to this occurrence.It is unknown if the patient experienced any adverse effects due to this occurrence.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: it was reported that the basket of a ngage nitinol stone extractor did not function properly during a ureteroscopy with stone extraction.It is unknown if a section of the device remained inside the patient¿s body.It is unknown if the patient required any additional intervention due to this occurrence.It is unknown if the patient experienced any adverse effects due to this occurrence.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, the instructions for use, manufacturing instructions, and quality control data.A device failure analysis was conducted on the returned device.The investigator made the following notation: the basket was returned in the open packaging.The handle was in between the open and closed positions.The support sheath was separated approximately 6mm from the mlla (male luer lock adapter).A separated section of support sheath appears to be stuck to basket sheath.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: important: excessive force could damage device.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to be nonfunctional due to sheath damage.The support sheath was separated near the handle.The cause for the damage was unknown.Excessive force may have been inadvertently applied to the device, however no information was known regarding device handling, therefore the cause of the issue could not be conclusively determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.

• Brand Name: NGAGE NITINOL 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 ; 8128294891
• MDR Report Key: 12519695
• MDR Text Key: 272925747
• Report Number: 1820334-2021-02204
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)240715(10)14091024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-022115
• Device Lot Number: 14091024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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