FDA.reportPublic FDA data

MAUDE MDR 4377194

MDR report key
4377194
Report number
9610614-2014-00019
Event key
0
Event type
3
Date of event
2014-11-26
Date received
2014-12-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JOHN TARGAL
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
1ERBE VIO 300 DELECTROSURGICAL GENERATORERBE ELEKTROMEDIZIN GMBHGEIVIO 300 D10140-000NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-1701. H

Event Narratives#

D

Patient 1

THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. A POLYPECTOMY WAS PERFORMED. THE ENDOCUT Q MODE WAS USED. AFTER REMOVING A LARGE POLYP, THE PHYSICIAN ATTEMPTED TO CAUTERIZE THE STUMP. NO OUTPUT WAS DELIVERED, NOR AUDIO OR ERRORING. THERE WAS SIGNIFICANT BLEEDING SO THE PATIENT WAS SENT FOR AN X-RAY AND POSSIBLE SURGERY. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL. NOTE: THE ACCOUNT STATED THAT AFTER THE INCIDENT THE ESU WAS TESTED AND FOUND TO BE FUNCTIONING PROPERLY.

N

Patient 1

AN OFFER WAS MADE TO THE ACCOUNT TO HAVE ERBE EVALUATE THE APC/ESU SYSTEM. AS APPLICABLE, FURTHER INFORMATION ON THE RESULTS OF THE EQUIPMENT WILL BE PROVIDED IN A FOLLOW-UP REPORT.