MAUDE Adverse Event Report: SIGHT SCIENCES, INC. VISCO360 VISCOSURGICAL SYSTEM; VISCOELASTIC INJECTOR

Model Number	03916
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device instructions for use were reviewed.They were found to be adequate and with no deficiencies.A review of the product lot history records for this lot of devices did not reveal any production nonconformance, anomaly or any other background that would help explain the circumstances for this complaint.The device was discarded by the facility and is not available for evaluation.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.(b)(4).
Event or Problem Description
The surgeon reported that the tip of the microcatheter was severed during use.The severed portion of the device was removed from the eye without incident.A new device was used to complete the case.The surgeon reported there were no intra-operative or post-operative adverse events associated with this device issue.

• Brand Name: VISCO360 VISCOSURGICAL SYSTEM
• Common Device Name: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill road, 3-105; menlo park CA 94025
• MDR Report Key: 6439506
• Report Number: 3010363671-2017-00010
• Device Sequence Number: 603550
• Product Code: MRH
• UDI-Device Identifier: 00858027006013
• UDI-Public: (01)00858027006013(17)171130(10)1005077
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143205
• 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
• Report Date (Section B): 02/23/2017

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: 11/30/2017
• Device Model Number: 03916
• Device Catalogue Number: 03916
• Device Lot Number: 1005077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1