MAUDE Adverse Event Report: DIROS TECHNOLOGY INC. RF TRIDENT CANNULA; PROBE, RADIOFREQUENCY LESION

Model Number	DTR-018/54/5
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.On fluoroscopic imaging, physician could see a tine.Fda safety report id # (b)(4).

• Brand Name: RF TRIDENT CANNULA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): DIROS TECHNOLOGY INC.; markham, ontario L3R 2 Z3; CA L3R 2Z3
• MDR Report Key: 11087022
• Report Number: MW5098548
• Device Sequence Number: 17203157
• Product Code: GXI
• UDI-Device Identifier: 00825114004597
• UDI-Public: 00825114004597
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR