MAUDE Adverse Event Report: SIGHT SCIENCES, INC. TRAB360 TRABECULOTOMY SYSTEM; TRABECULOTOME

Model Number	03706
Medical Device Problem Codes	Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information currently available to sight sciences, inc.Has been submitted.The returned product is being evaluated by the company and a follow-up report will be submitted when the investigation is complete.The company is submitting this mdr to ensure full compliance with 21 cfr 803.(b)(4).
Event or Problem Description
The surgeon reported severing the trabeculotome while performing a trabeculotomy.The severed portion of the device was lodged in schlemm's canal.The entire device was removed from the eye.There is no known adverse impact to the patient.
Additional Manufacturer Narrative
Added data: provided device evaluation report.Mfr reference #: (b)(4).

• Brand Name: TRAB360 TRABECULOTOMY SYSTEM
• Common Device Name: TRABECULOTOME
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• MDR Report Key: 6883741
• Report Number: 3010363671-2017-00028
• Device Sequence Number: 13612258
• Product Code: HMZ
• UDI-Device Identifier: 00858027006112
• UDI-Public: (01)00858027006112
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: 03706
• Device Catalogue Number: 03706
• Device Lot Number: 1005564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR