LIGHT SOURCE, 500XL, XENON 72200568

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for LIGHT SOURCE, 500XL, XENON 72200568 manufactured by Smith & Nephew, Inc..

Event Text Entries

[127351347] (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[127351348] It was reported that the device overheated. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1643264-2018-00886
• MDR Report Key: 8075686
• Date Received: 2018-11-15
• Date of Report: 2018-12-27
• Date Mfgr Received: 2018-12-26
• Date Added to Maude: 2018-11-15
• 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
• 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: 76 S. MERIDIAN AVE.
• Manufacturer City: OKLAHOMA CITY OK 731076512
• Manufacturer Country: US
• Manufacturer Postal Code: 731076512
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LIGHT SOURCE, 500XL, XENON
• Generic Name: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Product Code: FFS
• Date Received: 2018-11-15
• Returned To Mfg: 2018-12-05
• Catalog Number: 72200568
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC.
• Manufacturer Address: 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-11-15