LUMITEX LIGHTMAT 005011 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-16 for LUMITEX LIGHTMAT 005011 * manufactured by Lumitex, Inc..

Event Text Entries

[3023617] The following are the manager's comments about the incident. "a fiberoptic retractor called a light mat has a disposable fiberoptic light that attaches to a non disposable light cord. The disposable portion is attached by the cst or the surgeon to a retractor and the distal end is attached to the light mat cord. The connection between the disposable fiberoptic light and the cord became very hot during this procedure and because that portion was distal to the actual retractor that the surgeon was holding he was not aware that the metal connection had become exceptionally hot. The scrub tech and the surgeon had protected the patient's skin with towels and drapes and taken care not to lay the retractor on the patient's skin. However at the end of the procedure several red blisters were noted on the patient's right breast. Upon investigation the cst and the surgeon found that the metal connection between the light cord and the fiberoptic light was exceptionally hot and realized that this portion of the light mat must have touched the patient's skin while the surgeon was using the light mat to retract. The surgeon and the cst had protected the patient's skin from the actual light end of the retractor but they did not realize that the distal metal connection was hot enough to burn the patient's skin. This metal portion should not be hot enough to cause a blister to the skin and the surgeon and the cst reported that the light mat needed to be inspected for the cause of the overheating. The light cord was given to the material manager who called the rep. The rep picked up the light cord and sent it to the company to be checked out. The literature that comes from the manufacturer says the light mat is to be used with a standard 300 watt xenon light source which is what was used for the case. The rep's solution was a plastic cage which fits over the metal portion of the light cord to protect the patient from the hot metal. He brought us this device called a cable buddy after the incident. He had never showed us this device before the incident and we have used the light mat product for at least 3 years now. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2814279
• MDR Report Key: 2814279
• Date Received: 2012-10-16
• Date of Report: 2012-10-16
• Date of Event: 2012-09-12
• Report Date: 2012-10-16
• Date Reported to FDA: 2012-10-16
• Date Added to Maude: 2012-11-01
• 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: 3
• 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: LUMITEX LIGHTMAT
• Generic Name: RETRACTOR, FIBEROPTIC
• Product Code: FDG
• Date Received: 2012-10-16
• Returned To Mfg: 2012-09-12
• Model Number: 005011
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 16 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LUMITEX, INC.
• Manufacturer Address: 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-10-16