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

Catalog Number NGE-017115-MB

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2022

Event Type  Injury  

Event Description

It was reported that the basket of a ngage nitinol stone extractor broke inside a patient during use.This event occurred during a ureteroscopy/rgpg/pyeloscopy/pcnl.When the physician removed the device from the scope, a piece of the device was noted to be stuck in the patients mid/proximal ureter.The provider then used a grasper the remove the foreign matter.The patient did not experience any adverse effects due to this occurrence.No additional procedure was required due to this occurrence.No additional adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.

Manufacturer Narrative

Summary of event: it was reported that the basket of a ngage nitinol stone extractor broke inside a patient during use.This event occurred during a ureteroscopy/rgpg/pyeloscopy/pcnl.When the physician removed the device from the scope, a piece of the device was noted to be stuck in the patients mid/proximal ureter.The provider then used a grasper the remove the foreign matter.The patient did not experience any adverse effects due to this occurrence.No additional procedure was required due to this occurrence.No additional adverse effect on the patient was reported due to this occurrence.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 of the returned complaint device was also conducted.The device was returned to cook in the original pouch and shipping tray.The device was in two segments.The first segment was the basket handle and main body, with approximately 104 centimeters of basket sheath.Approximately 3 millimeters of the internal assembly was protruding from the point of separation.The second segment was approximately 9.6 centimeters of the basket sheath, with the basket assembly protruding from the end.The basket wires were still intact.The separated ends of the basket sheath and basket subassembly were cut cleanly, indicating the separation occurred from contact with a sharp object as opposed to being broken from a large tensile force being applied.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were 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 the 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: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.It is possible another device being used during the procedure, such as the scope, had a sharp edge that contacted the sheath of the basket device, resulting in the observed separation.However, cook has concluded that the cause of the issue could not be conclusively determined with the available information.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: 14468636
• MDR Text Key: 292350644
• Report Number: 1820334-2022-00955
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482958
• UDI-Public: (01)10827002482958(17)250317(10)14604713
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 14604713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Female