MAUDE Adverse Event Report: IRIDEX CORPORATION SINGLE G-PROBE RFID SINGLE; POWERED LASER SURGICAL INSTRUMENT

Model Number 15980-1

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Event Description

The iridex g probe was tested before it was used on a patient.During the test, the probe burned the packaging.Another probe was also tested, which did not burn the packaging.

• Brand Name: SINGLE G-PROBE RFID SINGLE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043
• MDR Report Key: 15796629
• MDR Text Key: 303635889
• Report Number: 15796629
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 15980-1
• Device Lot Number: 900681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1