TRUMPF TRULI5000 SERIES 1HD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-31 for TRUMPF TRULI5000 SERIES 1HD manufactured by Trumpf Medical Systems, Inc..

Event Text Entries

[109943800] Pt was having surgery and during the procedure, the surgeon noted that the incision site was very hot to touch. The patient had burn sites on the skin. There were three trumpf medical lights in use during the procedure that were deemed to have caused the burn to the skin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077578
• MDR Report Key: 7560548
• Date Received: 2018-05-31
• Date of Report: 2018-05-30
• Date of Event: 2018-03-08
• Date Added to Maude: 2018-06-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: TRUMPF
• Generic Name: LIGHT, SURGICAL, INSTRUMENT
• Product Code: FSQ
• Date Received: 2018-05-31
• Model Number: TRULI5000 SERIES 1HD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: TRUMPF MEDICAL SYSTEMS, INC.

Device Sequence Number: 1

• Brand Name: TRUMPF
• Generic Name: LIGHT, SURGICAL, INSTRUMENT
• Product Code: FSQ
• Date Received: 2018-05-31
• Model Number: TRULI5000 SERIES 1HD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TRUMP MEDICAL SYSTEMS, INC.

Device Sequence Number: 2

• Brand Name: TRUMPF
• Generic Name: LIGHT, SURGICAL, INSTRUMENT
• Product Code: FSQ
• Date Received: 2018-05-31
• Model Number: TRULI5000 SERIES 1HD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: TRUMP MEDICAL SYSTEMS, INC.

Device Sequence Number: 3

• Brand Name: TRUMPF
• Generic Name: LIGHT, SURGICAL, INSTRUMENT
• Product Code: FSQ
• Date Received: 2018-05-31
• Model Number: TRULI5000 SERIES 1HD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: TRUMP MEDICAL SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2018-05-31