MAUDE Adverse Event Report: DIROS TECHNOLOGY INC. OWL (18GA.) RF INSULATED HYBRID CANNULA

Model Number	DHC-018/150/10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physician decided to open the skin and remove the broken fragment.The physician informed the patient about the incident.The patient did not and has not reported any issues.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.Manufacturer detected the device shaft was severely bent indicative of excessive force which may have caused the breakage.
Event or Problem Description
During the placement of the device, the physician noticed that part of the hybrid rf cannula's shaft became detached and remained in the patient.The returned device to manufacturer was found to be severely bent.

• Brand Name: OWL (18GA.) RF INSULATED HYBRID CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): DIROS TECHNOLOGY INC.; 120 gibson drive; markham, ontario L3R 2 Z3; CA L3R 2Z3
• Manufacturer Contact: 120 gibson drive; markham, ontario L3R 2-Z3
• MDR Report Key: 14115818
• Report Number: 8043398-2022-00001
• Device Sequence Number: 14605623
• Product Code: GXI
• UDI-Device Identifier: 00825114006799
• UDI-Public: 00825114006799
• Combination Product (Y/N): N
• PMA/510(K) Number: K102566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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: 01/07/2025
• Device Model Number: DHC-018/150/10
• Device Catalogue Number: DHC-018/150/10
• Device Lot Number: 6654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian