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

Catalog Number	1-108
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon who performed an omni procedure reported that the microcatheter kept springing back in the canal while trying to retract the device after completing the canaloplasty in the first hemisphere.Both index fingers had to be used to retract and hold the micro catheter in place so the device could be removed without inadvertently tearing the trabecular meshwork.A new device was used to complete the canaloplasty and goniotomy procedure in the second hemisphere.There was no patient injury that was reported.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OMNI SURGICAL SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES INC.,; 4040 campbell avenue; suite 100; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES INC.,; 4040 campbell avenue; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell avenue; suite 100; menlo park, CA 94025
• MDR Report Key: 19955502
• Report Number: 3010363671-2024-00009
• Device Sequence Number: 12986126
• Product Code: MRH
• UDI-Device Identifier: 00858027006525
• UDI-Public: 00858027006525
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1-108
• Device Lot Number: F23J11-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/09/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown