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

Catalog Number NGE-022115-MB

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

As reported, after opening the sterile package of a ngage nitinol stone extractor, it was noted that the basket could not be opened.The wire next to the "grip" was bent.There was no visible damage to the device packaging.The device was planned to be used in a ureteroscopy (urs) procedure, and it was tested prior to use.No laser was noted to be used.There was nothing noted in the patient's anatomy that would have kept the basket from opening.A new basket was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Initial reporter occupation: occupation: sister.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, after opening the sterile package of a ngage nitinol stone extractor, it was noted that the basket could not be opened.The wire next to the "grip" was bent.There was no visible damage to the device packaging.The device was planned to be used in a ureteroscopy (urs) procedure, and it was tested prior to use.No laser was noted to be used.There was nothing noted in the patient's anatomy that would have kept the basket from opening.A new basket was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence corrected information: h6 (annex g).Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the returned complaint device was also conducted.The complaint device was returned loose in original pouch without a shipping tray.The basket was closed and could not be opened.The basket sheath was bent/kinked 1 cm from the yellow support sheath.Cook completed a review of the device history record (dhr).The dhr for the reported lot found 2 potentially relevant non-conformances, one for basket will not open/close and the other for a bent/kinked.However, all non-conforming product was scrapped.A lot history search found no other complaints had been reported for this lot.All devices are inspected for functionality and damage during manufacturing and quality control checks and the complaint devices passed those inspections.Because adequate inspection activities have 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.A review of relevant manufacturing and quality control documents was conducted.All extractors are verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: suggested handling instructions for extractors and forceps caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Cook has concluded that the cause for the reported issue could not be conclusively determined.Excessive force may have been inadvertently applied to the device, but no information was known regarding device handling.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

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

• 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 ; 8123392235
• MDR Report Key: 13929271
• MDR Text Key: 288503334
• Report Number: 1820334-2022-00469
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482965
• UDI-Public: (01)10827002482965(17)241213(10)14412141
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 14412141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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