MAUDE Adverse Event Report: SIGHT SCIENCES, INC. OMNI SURGICAL SYSTEM; OPHTHALMIC INFUSION PUMP

Model Number	1-102
Medical Device Problem Codes	Break (1069); Stretched (1601); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The omni surgical system device that was used by the surgeon and which a separation of the polymeric microcatheter from the device occurred was returned and evaluated by sight sciences engineers.An analysis of historical customer complaints showed that this failure mode has not previously occurred with this specific design (i.E., catalog/model #: 1-102).A review of the manufacturing records did not reveal any anomalies or other potential root causes of this complaint.The engineers examined the returned device and it appeared to function as expected, in accordance with required specifications.The stainless steel cannula is designed with a sharpened tip and was likely associated with the "separation" of the polymeric microcatheter; however, the dimensional and surface finish characteristics of the cannula were within specification, having the intended design for contact interface with the polymeric microcatheter.The "separated" microcatheter was closely examined and appeared to have been stretched and torn and possibly cut, although it did not appear to be a clean "severed" cut by the sharp cannula.The root cause could not be determined.Two potential root causes are (1) a minor defect in the microcatheter (such as a cut or hole), either created during manufacturing or in actual use of the device, became caught on the sharp stainless-steel cannula tip and tore a portion of the microcatheter from the device, or (2) the surgeon may have applied a technique during the trabeculotomy procedure that inadvertently kinked the microcatheter, causing it to orient in a sharp angle relative to the stainless-steel cannula and was subsequently stretched and ultimately severed by the cannula.The surgeon was able to easily visualize the severed microcatheter and quickly retrieve it with forceps.The patient was reported to be in "very good" condition at the conclusion of the procedures.
Event or Problem Description
On (b)(6) 2020, the surgeon was treating the right eye of a (b)(6) year-old female patient with the omni surgical system (catalog #: 1-102, lot #: 1008143).Upon completing a trabeculotomy of the second hemisphere of schlemm's canal, the microcatheter "disconnected from the device" and was freely in the anterior chamber of the patient's eye.The surgeon removed the piece of the microcatheter with forceps.After the procedure, the patient's condition was reported as "very good.".

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: OPHTHALMIC INFUSION PUMP
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 4040 campbell ave.; suite 100; menlo park CA 94025
• MDR Report Key: 10591094
• Report Number: 3010363671-2020-00005
• Device Sequence Number: 16838956
• Product Code: MRH
• UDI-Device Identifier: 00858027006372
• UDI-Public: 010085802700637217210630101008143
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173332
• 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): 09/25/2020

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: 06/30/2021
• Device Model Number: 1-102
• Device Catalogue Number: 1-102
• Device Lot Number: 1008143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR