MAUDE Adverse Event Report: IRIDEX G-PROBE SINGLE

Catalog Number	11256-1
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician began using a diode laser with a g probe.He stated that the probe burned the eye.Physician requested another g probe and it worked correctly with no problems.After the procedure physician requested drugs/eye drops to treat the burned area of the eye.An eye patch and eye shield was applied to the eye.

• Brand Name: G-PROBE SINGLE
• Common Device Name: G-PROBE SINGLE
• Manufacturer (Section D): IRIDEX; mountain view CA 94043
• MDR Report Key: 6553886
• Report Number: MW5069643
• Device Sequence Number: 1033041
• Product Code: GEX
• UDI-Device Identifier: 00851089000234
• UDI-Public: 01008510890002341720022810016545
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 11256-1
• Device Lot Number: 016545
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 48