MAUDE Adverse Event Report: SIGHT SCIENCES INC OMNI SURGICAL SYSTEM

Catalog Number 1-102

Device Problem Material Fragmentation (1261)

Patient Problem Hyphema (1911)

Event Date 07/12/2023

Event Type  Injury  

Event Description

The physician using an omni device, reported that the catheter broke while performing the retracting the device.The broken off part of the device was removed using a forceps.There was hyphema >1mm that was noted.

• Brand Name: OMNI SURGICAL SYSTEM
• Type of Device: 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 ave; suite 100; menlo park CA 94025
• Manufacturer Contact: ranjani madhavan ; 4040 campbell ave; suite 100; menlo park, CA 94025
• MDR Report Key: 17620043
• MDR Text Key: 321920418
• Report Number: 3010363671-2023-00021
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 00858027006372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1-102
• Date Manufacturer Received: 07/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other