MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	G2-W-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device was not available; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Use injury is identified as a known inherent risk of trabecular micro-bypass stent procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.An adverse event appears to have occurred, but does not appear to have been a problem with the device or the way it was used.Use injury is an established risk associated with use of the device, which is clearly specified documented.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that during a trabecular microbypass stent system procedure, the surgeon inadvertently "poked the nurse''s finger with the trocar" during device transfer.Reportedly, the nurse is "fine" and had subsequent "blood test and injection".There was no report of patient injury.Additional information has been requested.
Event or Problem Description
Through follow-up, the following additional information was received.Per report, there was no adverse effect on the nurse, no further intervention required and the event resolved.The report noted the event was "by accident".
Additional Manufacturer Narrative
Mfr# reference: (b)(4).
Additional Manufacturer Narrative
The evaluation of the returned device was completed, and the x-ray revealed that the cam assembly was activated once and one (1) stent was found.The trigger button motion was functioning as intended, and the device was able to actuate all remaining positions.The device was disassembled and visually inspected.No non-conformances related to the reported event were found.Based on the investigation and these findings, the root cause of the customer¿s reported issue could not be conclusively identified.Mfr# reference: (b)(4).

• Brand Name: ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer (Section G): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: brittany massey ; 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 19378262
• Report Number: 2032546-2024-00054
• Device Sequence Number: 15379499
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 0100853704002319
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: G2-W-US
• Device Lot Number: 316082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/12/2024; 07/10/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/14/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Asian