MAUDE Adverse Event Report: TRICE MEDICAL MI-EYE 2 CAMERA ENABLED PROBE; ARTHROSCOPE

Model Number	T200-095
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physician reported the infection to trice medical on (b)(6) 2021; procedure was performed on the patient one week prior, on (b)(6) 2021.Physician reported to trice medical during discussion on (b)(6) 2021 that he did not expect that the trice mi-eye 2 was the cause of the infection.He stated that he typically has 1-2 patients per year present with infection post injection procedure.Until this incident, none of those infections occurred when performing injections using the mi-eye 2.The physician had already discarded the device used because it was a week after the procedure when he was made aware of the infection.
Event or Problem Description
Patient presented with local infection near the procedure site.Patient procedure included a mi-eye 2 camera as well as skin preparation materials, gel-one, and steroid injection through luer port of mi-eye 2.Physician described that the patient required surgery to clean the infection site and required a course of antibiotics to be administered in the hospital.The physician described that he used typical skin preparation procedures to clean the procedure site prior to insertion of the trice mi-eye 2 camera enabled probe.

• Brand Name: MI-EYE 2 CAMERA ENABLED PROBE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): TRICE MEDICAL; 4 general warren blvd; suite 100; malvern PA 19355
• MDR Report Key: 11529573
• Report Number: 3010760216-2021-00001
• Device Sequence Number: 14580584
• Product Code: HRX
• UDI-Device Identifier: 00861578000331
• UDI-Public: 00861578000331
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: T200-095
• Device Lot Number: 2002032401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR