FDA.reportPublic FDA data

MAUDE MDR 4162845

MDR report key
4162845
Report number
1220865-2014-00005
Event key
0
Event type
3
Date of event
2014-09-16
Date received
2014-10-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRIS MANNARINO
Address
1950 HANNAHAN ROAD CHARLESTON SC 29406 US
Phone
843-843-8435
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHROMOPHARECEILING MOUNTED SURGICAL LIGHTBERCHTOLDFQP660Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-0801. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A URETERAL PYELOURETEROSTOMY SURGICAL PROCEDURE, A PATIENT (BABY), WAS ALLEGEDLY BURNED WHILE TWO LIGHTS WERE FOCUSED ON THE SURGICAL SITE. THE PATIENT WAS REFERRED TO DERMATOLOGY AND IT WAS DETERMINED THAT THE PATIENT RECEIVED A 2ND DEGREE BURN. THE PATIENT WAS TREATED WITH SILVADENE 1 PERCENT CREAM AND WAS ADVISED TO CONTINUE THAT TREATMENT TWICE DAILY.

N

Patient 1

IT WAS REPORTED THAT DURING A URETERAL PYELOURETEROSTOMY SURGICAL PROCEDURE, A PATIENT (BABY), WAS BURNED WHILE TWO LIGHTS WERE FOCUSED ON THE SURGICAL SITE. THROUGH INVESTIGATION BETWEEN THE CUSTOMER AND BERCHTOLD SERVICE TECHNICIAN, IT WAS DETERMINED THAT BOTH LIGHTS WERE FOCUSED ON THE SURGICAL SITE, THE INTENSITY WAS AT IT'S HIGHEST, THE LIGHT SPOT WAS ABOUT 6 INCHES AND THE HEALTH CARE PROFESSIONALS DID NOT REVIEW THE USER MANUAL. THE USER MANUAL PROVIDED TO THE CUSTOMER WARNS "THE OVERLAY OF THE LIGHT FIELDS CAN CAUSE AN INCREASE IN HEAT GENERATION". THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR.