MAUDE Adverse Event Report: SIGHT SCIENCES INC. OMNI SURGICAL SYSTEM

Model Number	FG 06721
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Physician using an omni device reported that the microcatheter portion broke-off while retracting the device.The broken-off part of the micro-catheter was retrieved using a utrata forceps without further incident.Surgeon reported increased cornea edema after the catheter removal with utrata forceps that resolved without further incident.
Additional Manufacturer Narrative
The returned device was carefully evaluated and was determined that there is no evidence that the device design or manufacturing process was the cause of the incident.A review of device lot history record concluded that there were no production non-conformances or any other anomalies that would have contributed to this event.Additionally, a review and analysis of most suspected components (i.E., cannula and catheter) was performed and did not find non-conformances or abnormalities (e.G., suspicious patterns) that may have contributed to the reported incident.Therefore, the probable root cause is likely due to a surgical technique or use error.A root cause is difficult to determine as there was no ssi representative present to witness the procedure while the event occurred.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OMNI SURGICAL SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES INC.; 4040, campbell ave; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCINECES INC.; 4040 campbell ave; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlopark, CA 94025
• MDR Report Key: 16856317
• Report Number: 3010363671-2023-00010
• Device Sequence Number: 12403236
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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
• Device Model Number: FG 06721
• Device Catalogue Number: 1-108
• Device Lot Number: F23A06-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown