MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION LUXTEC ULTRALITE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number 001270BIF

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

During surgery it was noticed that the headlamp being worn by the surgeon was smoking and melting.

• Brand Name: LUXTEC ULTRALITE
• Type of Device: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 22 terry avenue; burlington MA 01803
• MDR Report Key: 4216339
• MDR Text Key: 4976631
• Report Number: 4216339
• Device Sequence Number: 0
• Product Code: FCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 001270BIF
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1