MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE; TANSSCLERAL PROBE

Model Number	11256
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of lot history and complaint history review indicate that this does not appear to be a systemic or recurring issue.No other similar reports were identified.The laser console associated with this incident has been in use for 27 years (22 years beyond its 5-year life expectancy).The physician's report indicates that the laser was being used off label to treat an indication for which the device is not cleared (i.E.Cataract removal).
Event or Problem Description
Per report, 0500170000-2019-8006, received at iridex from fda: "the physician reported that the laser did not appear to be working.The physician reported that the laser misfired after a new g probe was connected.The procedure was discontinued and the patient was not harmed".

• Brand Name: G-PROBE
• Common Device Name: TANSSCLERAL PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 tarre bella avenue; mountain view CA 94043 1824
• MDR Report Key: 8471836
• Report Number: 2939653-2019-00004
• Device Sequence Number: 1781226
• Product Code: GEX
• UDI-Device Identifier: 00851089000234
• UDI-Public: 0851089000234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K913430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: No Information
• Device Expiration Date: 06/28/2020
• Device Model Number: 11256
• Device Lot Number: 016653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1
• Patient Age: 65 YR