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

Model Number 05600

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2018

Event Type  malfunction  

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 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
• Type of Device: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer Contact: anne-marie ripley ; 3000 sand hill rd., 3-105; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 8254038
• MDR Text Key: 133339974
• Report Number: 3010363671-2019-00001
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006310
• UDI-Public: (01)00858027006310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR