XENON 300 HEADLIGHT BOX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-30 for XENON 300 HEADLIGHT BOX * manufactured by Unk.

Event Text Entries

[17838888] Surgeon was using fiberoptic retractor attached to headlight box; noted burning smell from back of headlight. Disconnected tip of fiberoptic cord from the headlight. Saw smoke at tip of fiberoptic cord. No harm to staff or patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3659224
• MDR Report Key: 3659224
• Date Received: 2014-01-30
• Date of Report: 2014-01-30
• Date of Event: 2014-01-14
• Report Date: 2014-01-30
• Date Reported to FDA: 2014-01-30
• Date Reported to Mfgr: 2014-03-05
• Date Added to Maude: 2014-03-05
• 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
• 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 Sequence Number: 1

• Brand Name: XENON 300 HEADLIGHT BOX
• Generic Name: LIGHT, SURGICAL HEADLIGHT
• Product Code: EBA
• Date Received: 2014-01-30
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: FIBEROPTIC RETRACTOR
• Generic Name: RETRACTOR
• Product Code: GAD
• Date Received: 2014-01-30
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-01-30