MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INJECT; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	G2-M-IS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient scheduled for cataract and i-stent surgery.The extracapsular cataract extraction was completed and the glaukos istent inject procedure started soon after.The istent device only fired once when it was supposed to have three fires in it.Another istent was opened and used in a successful procedure.The patient was sent back to same day surgery area.

• Brand Name: ISTENT INJECT
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 10152846
• Report Number: 10152846
• Device Sequence Number: 13965732
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: (01)00853704002203
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020
• Report Date (Section F): 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G2-M-IS
• Device Catalogue Number: G2-M-IS
• Device Lot Number: 126004
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/02/2020