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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. REPAIR, LIGHTSOURCE LX300 SERI
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INTEGRA BURLINGTON, MA, INC. REPAIR, LIGHTSOURCE LX300 SERI Back to Search Results
Catalog Number R00LX300
Device Problem Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Type  Injury  
Event Description
The customer reports to sales representative that a tebbetts fiberoptic retractor, product number (b)(4) (they believe is made by (b)(4)) was being used on a double mastectomy with reconstruction.The retractor was attached to an acmi fiberoptic cable product number g93 and that was plugged in to the lx300."the connection between the cord and the retractor gets hot and the surgeons have been dealing with this for years but never said anything.The patient had a 'belly' and they had to lean down causing 3 burns - 2 under the left breast and 1 at the midline.".
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
 
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Brand Name
REPAIR, LIGHTSOURCE LX300 SERI
Type of Device
NA
Manufacturer (Section D)
INTEGRA BURLINGTON, MA, INC.
burlington MA 01803
Manufacturer Contact
sandra lee
315 enterprise dr.
6099366828
MDR Report Key3412994
MDR Text Key3908344
Report Number1222895-2013-00022
Device Sequence Number1
Product Code FCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K864385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/10/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberR00LX300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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