LIGHT SOURCE, LED 3000 72204011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for LIGHT SOURCE, LED 3000 72204011 manufactured by Smith & Nephew, Inc..

Event Text Entries

[130322210]
Patient Sequence No: 1, Text Type: N, H10

[130322211] It was reported that the light source board is out; it has no light. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003604053-2018-00193
• MDR Report Key: 8155313
• Date Received: 2018-12-12
• Date of Report: 2019-01-03
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2018-12-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JIM GONZALES
• Manufacturer Street: 7000 WEST WILLIAM CANNON DRIVE
• Manufacturer City: AUSTIN TX 78735
• Manufacturer Country: US
• Manufacturer Postal: 78735
• Manufacturer Phone: 5123585706
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 150 MINUTEMAN ROAD
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal Code: 01810
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LIGHT SOURCE, LED 3000
• Generic Name: CAMERA, TELEVISION, SURGICAL, WITH AUDIO
• Product Code: FWC
• Date Received: 2018-12-12
• Catalog Number: 72204011
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC.
• Manufacturer Address: 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-12