FDA.reportPublic FDA data

MAUDE MDR 2181936

MDR report key
2181936
Report number
1720159-2007-00037
Event key
0
Event type
3
Date of event
2007-08-07
Date received
2007-08-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JEFF DICKINSON
Address
14603 E. FREMONT AVE. CENTENNIAL CO 80112 US
Phone
800-800-8005
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CONMEDSUCTION COAGULATORCONMED ELECTROSURGERYFEH60-6900-00107AHL003Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-3001. O; 2. R

Event Narratives#

D

Patient 1

PER THE BIOMED (B)(6), HE STATED THAT DURING SURGERY THIS MORNING A FEMALE PT DEVELOPED A BURN AT THE RIGHT CORNER OF HER MOUTH WHERE THE LIPS MEET FROM A PIN HOLE BREACH THAT THE SURGEON FEELS DEVELOPED IN THE SUCTION COAGULATOR DURING SURGERY - THIS ITEM HAD BEEN CHECKED OUT BEFORE THE SURGERY AND NO DEFECTS WERE DISCOVERED AT THAT TIME. THE PT WAS HAVING HER TONSILS AND ADENOIDS REMOVED. PLASTIC SURGEONS WERE CALLED IN AFTER THE BURN WAS DISCOVERED. THE PT RECEIVED STITCHES AT THE BURN SITE AND WAS MOVED TO RECOVERY. PER THE OPERATING ROOM MANAGER, THE PT IS DOING VERY WELL.

N

Patient 1

THE RETURNED DEVICE WAS EVALUATED AND CONFIRMED TO HAVE AN ENERGY BREACH. THE DAMAGE DONE TO THE DEVICE MAKES IT DIFFICULT TO IMPOSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. ADDITIONAL DEVICES OF THE SAME PART NUMBER, AND LOT NUMBER CLOSE TO SUSPECT DEVICE'S LOT NUMBER WERE TESTED. THESE ADDITIONAL TESTS REVEALED NO FAILURES. THIS DEVICE IS BEND-ABLE. IT MAY BE POSSIBLE THAT THE USER USED SOME SORT OF DEVICE/TOOL TO BEND THE PRODUCT, POSSIBLY COMPROMISING THE INSULATION. THE USER FACILITY CANNOT CONFIRM THIS. ANY ADDITIONAL INFO OBTAINED THROUGH OUR INVESTIGATIONS WILL BE FORWARDED TO THE FDA.