MAUDE Adverse Event Report: SIGHT SCIENCES, INC. OMNI SURGICAL SYSTEM; VISCOELASTIC INJECTOR

Model Number	05600
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to sight sciences, inc.Has been submitted.The company is submitting this mdr to ensure full compliance with 21 cfr part 803.Mfr reference #: (b)(4).
Event or Problem Description
On (b)(6) 2018, the surgeon advanced the microcatheter of the omni surgical system into schlemm's canal.As he began to retract the microcatheter, he observed that is was detached from cannula and remained in the canal.He grasped the detached portion with forceps and completed the goniotomy superiorly.He then used the forceps to thread the microcatheter into the other direction of schlemm's canal and created a goniotomy inferiorly.He then removed the microcatheter from the eye with the forceps.There were no intraoperative or post-operative complications associated with this product issue.

• Brand Name: OMNI SURGICAL SYSTEM
• Common Device Name: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• MDR Report Key: 8254038
• Report Number: 3010363671-2019-00001
• Device Sequence Number: 1439875
• Product Code: MRH
• UDI-Device Identifier: 00858027006310
• UDI-Public: (01)00858027006310
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 01/31/2020
• Device Model Number: 05600
• Device Catalogue Number: 1-100
• Device Lot Number: 1006652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR