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	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician successfully performed 180 degree canalplasty utilizing an omni device.Upon second advancement, the physician reporter the microcatheter buckled and snapped.The broken part of the microcatheter was removed from the canal.
Additional Manufacturer Narrative
The returned device was evaluated and was determined that there is no evidence that the device design or manufacturing process was the cause of the incident based on a review of the lot history and relevant components of the returned device.A video of the actual procedure was not available and therefore a definitive root cause could not be determined; however, the probable root cause for this incident is likely due to a surgical technique or use error based on: 1) returned device found to meet specification, and 2) user history of this physician as well as review of past similar complaints reported by other physicians, where videos of the procedure was provided, 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: rachel franco ; 4040 campbell ave.; suite 100; menlo park, CA 94025
• MDR Report Key: 18490139
• Report Number: 3010363671-2023-00027
• Device Sequence Number: 3533562
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: F23E11-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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