MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR

Catalog Number NGE-022115

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that a patient underwent a retrograde intra renal surgery (rirs) procedure.While attempting to retrieve the stone, the forcep would not work.The device was replaced and the attending physician indicated that the flexible ureteroscope was placed in the left percutaneous nephrostolithotomy (pcn) using an ngage nitinol stone extractor.The procedure was successful and there were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

A review of the following: functional test, review of complaint history, review of device history record, review of manufacturing instructions, review of quality control, and visual inspection.A functional test was performed and the udh handle did not actuate the basket format.A visual examination of the device noted the basket sheath is kinked approximately 1 cm from the distal tip and again at 37 cm from the distal tip.The handle was disassembled and the basket formation could not be manually actuated.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation the root cause is unknown.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6460669
• MDR Text Key: 72090747
• Report Number: 1820334-2017-00565
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)190815(10)7193992
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-022115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 60