FDA.reportPublic FDA data

MAUDE MDR 360338

MDR report key
360338
Report number
9610614-2001-00010
Event key
0
Event type
3
Date of event
2001-10-05
Date received
2001-11-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JOHN TARTAL
Address
2225 NORTHWEST PARKWAY MARIETTA GA 30067 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ERBOTOM ICC 200 EELECTROSURGICAL GENERATORERBE ELEKTROMEDIZIN GMBHGEIICC 200 E10128-204*K933157NNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-11-0601. L

Event Narratives#

D

Patient 1

ON 2001, ONE OF THE CO'S SALES REP WAS INFORMED BY THE MGR (NURSE) THAT AN INJURY (I.E., PERFORATION) OCCURRED DURING A COLONOSCOPY. THE DR REMOVED SEVERAL POLYPS USING THE ELECTROSURGICAL GENERATOR. THREE WERE REMOVED BY HOT BIOPSY FORCEPS AND ONE WAS REMOVED USING A SNARE TECHNIQUE. FOR THE HOT BIOPSY, THE SETTING WAS 60 WATTS OF SOFT COAG IN 2 TO 3 SECOND INTERVALS TOTALING 15 SECONDS. HOWEVER, 48 HOURS POST-PROCEDURE THE PT WAS STILL IN PAIN; THEREFORE, A TEST FOR THE COLON BEING BREACHED WAS PERFORMED. A PERFORATION WAS DIAGNOSED IN THE RIGHT COLON FROM REMOVING ONE OF THE POLYPS THAT WAS IN A FOLD USING THE HOT BIOPSY FORCEPS.