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

Catalog Number	1-108
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician using an omni device, reported that the catheter snapped in the eye under no pressure while performing the procedure.The severed part of the microcatheter was retrieved using a microforceps.
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.A video of the actual procedure was not available for ssi's review and therefore a definitive root cause cannot be determined; however, the probable root cause for this incident is likely due to a surgical technique or use error based on: 1) review of this physician's user history and 2) review of past similar complaints reported by other physicians where videos of the procedure were provided to ssi determined the incident occurred due to a surgical technique or use error.

• 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: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 18213693
• Report Number: 3010363671-2023-00025
• Device Sequence Number: 17795403
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: 00858027006525
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Catalogue Number: 1-108
• Device Lot Number: 54520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 02/22/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown