SOLARMAXX300 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-13 for SOLARMAXX300 * manufactured by Sunoptic.

Event Text Entries

[15820725] Light source was not adequate for performing surgery; not lighting enough.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4251782
• MDR Report Key: 4251782
• Date Received: 2014-10-13
• Date of Report: 2014-10-13
• Date of Event: 2014-10-09
• Report Date: 2014-10-13
• Date Reported to FDA: 2014-10-13
• Date Reported to Mfgr: 2014-11-14
• Date Added to Maude: 2014-11-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOLARMAXX300
• Generic Name: LIGHT, SURGICAL, FLOOR STANDING
• Product Code: FSR
• Date Received: 2014-10-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 2 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SUNOPTIC
• Manufacturer Address: 6018 BOWDENDALE AVENUE JACKSONVILLE FL 32216 US 32216

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-10-13