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U.S. Department of Health and Human Services

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

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INTEGRA YORK PA, INC. INTEGRA LUXTEC ROLLING LIGHT SOURCE SOURCE, CARRIER, FIBEROPTIC LIGHT Back to Search Results
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.
 
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Brand NameINTEGRA LUXTEC ROLLING LIGHT SOURCE
Type of DeviceSOURCE, CARRIER, FIBEROPTIC LIGHT
Manufacturer (Section D)
INTEGRA YORK PA, INC.
589 davies drive
york PA 17402
MDR Report Key6144863
MDR Text Key61442451
Report Number6144863
Device Sequence Number1
Product Code EQH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2016
Event Location Hospital
Date Report to Manufacturer11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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