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

Model Number	03706
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
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 803.Mfr reference #: (b)(4).
Event or Problem Description
The surgeon reported severing the tip of the trabeculotome while performing a trabeculotomy.The entire device was removed from the eye without incident.A new device was successfully used to complete the case.The event did not result in any adverse impact to the patient.
Additional Manufacturer Narrative
Corrected data: the initial report contained an error where the 510(k) number provided was incorrect.This device involved in this event is 510(k) exempt and there is no associated 510(k) number.

• Brand Name: TRAB360 TRABECULOTOMY SYSTEM
• Common Device Name: TRABECULOTOME
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill road, 3-105; menlo park CA 94025
• MDR Report Key: 6433193
• Report Number: 3010363671-2017-00003
• Device Sequence Number: 1042697
• Product Code: HMZ
• UDI-Device Identifier: 00858027006112
• UDI-Public: 0100858027006112
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132494
• 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): 11/30/2016

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: 11/30/2017
• Device Model Number: 03706
• Device Catalogue Number: 03706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1