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

Model Number	FG 06721
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician using an omni device reported that the microcatheter released from the handpiece during initial deployment.No injury reported and the broken portion of the microcatheter was withdrawn using forceps without further incident.

• 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 SCIENCES, INC; 4040 campbell ave; suite 100; menlo park CA 94025
• Manufacturer Contact: rachel franco ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 16482955
• Report Number: 3010363671-2023-00007
• Device Sequence Number: 7579039
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG 06721
• Device Catalogue Number: 1-102
• Device Lot Number: F22F16-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown