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

Catalog Number NGE-017115-MB

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

As reported, during a left flexible pyeloscopy with laser and extraction of left renal calculi, an ngage nitinol stone extractor would not fully close.The device was tested prior to use without issue.Following the lasering of a large renal calculus, the device was introduced via a 45cm flexor sheath to extract the stone fragments.Access to the kidney was described as "easy".After extraction of a few fragments, the basket would not fully close.The device was continued to be used until it could not longer retrieve stone fragments.The device was then removed from the patient, and a new device of the same type was used to successfully complete the procedure.No damage was noted to the device.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

Name and address- phone: (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.

Manufacturer Narrative

Event summary: as reported, during a left flexible pyeloscopy with laser and extraction of left renal calculi, an ngage nitinol stone extractor would not fully close.The device was tested prior to use without issue.Following the lasering of a large renal calculus, the device was introduced via a 45cm flexor sheath to extract the stone fragments.Access to the kidney was described as "easy".After extraction of a few fragments, the basket would not fully close.The device was continued to be used until it could not longer retrieve stone fragments.The device was then removed from the patient, and a new device of the same type was used to successfully complete the procedure.No damage was noted to the device.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.Investigation - evaluation: a document-based investigation was performed including a review of manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.No photos were provided.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.Because there were no known related non-conformances, adequate inspection activities had been established, and no other known 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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: important: excessive force could damage device.Information supplied by the user states no damage to the device was noted.It was not possible to determine the cause of the issue.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.

Event Description

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

• 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: 12990639
• MDR Text Key: 286352700
• Report Number: 1820334-2021-02667
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: COOK FUS-120045; COOK HLF-S273-H30; STORZ DIGITAL URETEROSCOPE
• Patient Sex: Male