MAUDE Adverse Event Report: INTEGRA YORK PA, INC. INTEGRA LUXTEC ROLLING LIGHT SOURCE; SOURCE, CARRIER, FIBEROPTIC LIGHT

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Event Description

Lux rolling light source began to smoke and smell of electric smoke so it was immediately unplugged and equipment moved away from patient and sequestered.No harm to patient.

• Brand Name: INTEGRA LUXTEC ROLLING LIGHT SOURCE
• Type of Device: SOURCE, CARRIER, FIBEROPTIC LIGHT
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies drive; york PA 17402
• MDR Report Key: 6144863
• MDR Text Key: 61442451
• Report Number: 6144863
• Device Sequence Number: 1
• Product Code: EQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR