MAUDE Adverse Event Report: OMNI SURGICAL SYSTEM; OPHTHALMIC INFUSION PUMP

Model Number	1-102
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was operating on the right eye of a 67 year old african american female patient using the omni surgical system.He successfully completed the canaloplasty portion in the inferior and superior hemispheres of the eye (360 degrees total).The physician then placed the microcatheter of the device into the schlemm's canal to perform a 180 degree trabeculotomy.When he finished about 45 degrees of trabeculotomy, the "microcatheter dislodged and fell in the anterior chamber." the physician used forceps to remove the portion of the omni surgical system microcatheter from the patient's eye.The event did not lead to any clinically noteworthy consequence.There was no injury to the endothelium or elsewhere in the anterior chamber.On followup, the physician reported that the patient is doing fine and there are no abnormal signs or symptoms reported as a result of the dislodged catheter.The patient is healing from the surgical procedures as expected.The slit lamp exam was within acceptable limits.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OPHTHALMIC INFUSION PUMP
• MDR Report Key: 11850140
• Report Number: 3010363671-2021-00002
• Device Sequence Number: 11550693
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: (01)00858027006372(17)230220(10)1008697
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1-102
• Device Catalogue Number: 1-102
• Device Lot Number: 1008697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR