FDA.reportPublic FDA data

MAUDE MDR 9391886

MDR report key
9391886
Report number
3006524618-2019-00579
Event key
0
Event type
3
Date of event
2019-11-10
Date received
2019-11-29
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
HOLLY TOPPING
Address
7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
Phone
512-512-5123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROCISE XP COBLATOR IIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIESARTHROCARE CORP.GEIEIC8872-011162435R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-290

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A NASAL MASS ABLATION PROCEDURE, THE METAL ELECTRODE WIRE OF THE WAND WAS FUSING AND BROKE. THERE WERE NO PIECES LEFT IN THE PATIENT AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.