MAUDE Adverse Event Report: SUNOPTIC SOLARMAXX300; LIGHT, SURGICAL, FLOOR STANDING

Device Problem Light Interference (2972)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Light source was not adequate for performing surgery; not lighting enough.

• Brand Name: SOLARMAXX300
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• Manufacturer (Section D): SUNOPTIC; 6018 bowdendale avenue; jacksonville FL 32216
• MDR Report Key: 4251782
• MDR Text Key: 15820725
• Report Number: 4251782
• Device Sequence Number: 1
• Product Code: FSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/13/2014

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
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2014
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 102