MAUDE Adverse Event Report: XENON 300 HEADLIGHT BOX; LIGHT, SURGICAL HEADLIGHT

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

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.

• Brand Name: XENON 300 HEADLIGHT BOX
• Type of Device: LIGHT, SURGICAL HEADLIGHT
• MDR Report Key: 3659224
• MDR Text Key: 17838888
• Report Number: 3659224
• Device Sequence Number: 1
• Product Code: EBA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/30/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR