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

Catalog Number NGE-017115-MB

Device Problem Material Separation (1562)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address- postal code: (b)(6).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.

Event Description

As reported, the coating of the basket sheath of an ngage nitinol stone extractor sheared off during laser lithotripsy.The device was inserted through another manufacturer's ureteroscope to extract stone fragments and the separated tip of a cook® single-use holmium laser fiber (see patient identifier: (b)(6)).Extraction of the tip was attempted with the ngage basket but was unsuccessful.Upon removal from the ureteroscope, the basket was damaged, and the plastic coating of the ngage basket had been sheared from a large proportion of the sheath of the basket.While attempting to move a stone fragment to a position more suitable for lasering, a consultant noted a "shiny clear small tube like object," possibly the laser fiber tip.A new ngage was used to attempt to remove the foreign object, but it was unable to be extracted.As bleeding began to obstruct the view of procedural imaging, a ureteric stent was placed, and the procedure was discontinued.A follow-up procedure was scheduled two weeks later to complete the stone extraction and remove the foreign object still in place.No unintended part of the ngage remained inside the patient's body.No adverse effect to the patient was reported due to this occurrence.

Event Description

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

Manufacturer Narrative

Event summary: as reported, the coating of the basket sheath of an ngage nitinol stone extractor sheared off during laser lithotripsy.The device was inserted through another manufacturer's ureteroscope to extract stone fragments and the separated tip of a cook® single-use holmium laser fiber (see patient identifier: (b)(6)).Extraction of the tip was attempted with the ngage basket but was unsuccessful.Upon removal from the ureteroscope, the basket was damaged, and the plastic coating of the ngage basket had been sheared from a large proportion of the sheath of the basket.While attempting to move a stone fragment to a position more suitable for lasering, a consultant noted a "shiny clear small tube like object," possibly the laser fiber tip.A new ngage was used to attempt to remove the foreign object, but it was unable to be extracted.As bleeding began to obstruct the view of procedural imaging, a ureteric stent was placed, and the procedure was discontinued.A follow-up procedure was scheduled two weeks later to complete the stone extraction and remove the foreign object still in place.No unintended part of the ngage remained inside the patient's body.No adverse effect to the patient was reported due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned in open packaging.Peeling of the plastic coating was noted throughout the entire basket sheath.The support sheet was severely bent.All fittings were tight on the handle.The handle could not actuate the basket.The handle was disassembled, and the basket could not be actuated manually.The product was received in the plastic clamshell in which parts of the basket sheath were smashed.Several kinks and bends were noted in the sheath, possibly due to the way it was returned.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device instructions for use includes the following: 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.The basket sheath of the returned device was found to have had a large amount of the clear outer portion of the sheath shaved off.The information provided stated a laser fiber used during the procedure also experienced damage.Based on the available information, cook has concluded that it is likely there was an issue with the scope being used in the procedure that caused damage to the devices used.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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: 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: 12615673
• MDR Text Key: 277489691
• Report Number: 1820334-2021-02316
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482958
• UDI-Public: (01)10827002482958(17)240812(10)14150971
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 14150971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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
• Treatment: BOSTON LITHOVUE SINGLE-USE URETEROSCOPE; COOK® SINGLE-USE HOLMIUM LASER FIBER