MAUDE Adverse Event Report: DIROS TECHNOLOGY INC RF TRIDENT CANNULA

Model Number DTR-018/54/5

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer narrative for fda report - (b)(4).Neither of the following outcomes resulted from the incident: death, life threatening situation, hospitalization, serious medical event, disability/permanent damage, congenital anomaly/birth defect, and required intervention to prevent permanent impairment/damage to the patient.When the device is received and additional information becomes available, further investigation will be completed and a follow-up report will be issued.

Event Description

It was reported to the manufacturer that after successfully performing 2 lesions for the supero-medial genicular nerve, upon retracting the cannula, a small piece about 1-2 mm from the distal part of one of the 3 tines was missing.Under fluoroscopic imaging, a tiny metallic point was observed near the site of lesioning.Subsequently, the patient was informed and agreed not to remove it.The procedure went on with a new cannula for the last lesion, the infero-medial genicular nerve without issue.It is expected that the device will be returned to the manufacturer along with fluoroscopic imaging for further analysis and to continue the investigation.

Manufacturer Narrative

Investigation of the device has shown that the damage to the tine has resulted from excessive mechanical force being applied on it during placement.Distinctive dents on the internal surface of the primary bevel are indicative of the movement of the device with partially deployed tines.Examination of the cross section of the broken tine doesn't show any damage or material defects.The incident was caused by improper usage of the device; the user did not follow the warnings and instructions provided in the ifu for the device.

• Brand Name: RF TRIDENT CANNULA
• Type of Device: CANNULA
• Manufacturer (Section D): DIROS TECHNOLOGY INC; 120 gibson drive; markham, ontario L3R 2 Z3; CA L3R 2Z3
• Manufacturer Contact: nick vahaviolos ; 120 gibson drive; markham, ontario L3R 2-Z3 ; CA L3R 2Z3
• MDR Report Key: 11072230
• MDR Text Key: 239160817
• Report Number: 8043398-2020-00001
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00825114004597
• UDI-Public: 00825114004597
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: DTR-018/54/5
• Device Catalogue Number: DTR-018/54/5
• Device Lot Number: 4766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2018
• 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 Age: 48 YR