FDA.reportPublic FDA data

MAUDE MDR 264632

MDR report key
264632
Report number
2916288-2000-00001
Event key
0
Event type
3
Date of event
2000-01-19
Date received
2000-02-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CINDY FEUSTEL
Address
2100 MERIDIAN PK. BLVD. CONCORD CA 94520 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OLSENELECTROSURGICAL MONOPOLAR FORCEPOLSEN ELECTROSURGICAL, INC.GEN413-D413-D020248NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-02-1801. O; 2. R

Event Narratives#

D

Patient 1

DURING TONSILLECTOMY SURGERY, PT WAS BURNED AT THE AREA SLIGHTLY ABOVE THE RIGHT CORNER OF THE MOUTH. THE BURN AREA EXCISED WAS APPROXIMATELY 4MM WIDE AND 1.5MM DEEP. THE HOSP EXAMINED THE FORCEP AND NOTED A 1/16 INCH DIAMETER VOID IN THE FORCEP INSULATION APPROXIMATELY 3 1/8 INCH FROM THE TIPS ON THE LEFT LEG OF THE FORCEP.