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	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The physician who performed omni surgery reported that the catheter kinked upon feeling resistance at about 90-100 degrees during the procedure.The catheter was stuck when trying to pull back to reengage.The catheter was stuck and could not be pulled back so it was pulled out by doing a goniotomy.The device was pulled out of the eye while trying to move the wheel forward or backwards and the catheter broke off (outside the eye).There was no intervention required as the catheter broke outside the eye.The procedure was completed using a fresh device.An evaluation of the returned device and a review of the lot history and relevant components of the returned device determined that there is no evidence that the device design or manufacturing process was the cause of the incident.A video of the actual procedure was not available and therefore a definitive root cause could not be determined; returned device found to meet specification, and user history of this physician as well as review of past similar complaints reported by other physicians, where videos of the procedure was provided the probable root cause for this incident is likely 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; 208 cherokee rose circle; georgetown TX 78626
• Manufacturer (Section G): SIGHT SCIENCES INC; 4040 campbell ave; suite 100; menlo park
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 19542548
• Report Number: 3010363671-2024-00007
• Device Sequence Number: 7513349
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: F23G24-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/14/2024
• 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