FDA.reportPublic FDA data

MAUDE MDR 3942008

MDR report key
3942008
Report number
1226420-2014-00051
Event key
0
Event type
3
Date of event
2014-06-18
Date received
2014-07-17
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
KAYLEE BOISVERT
Address
180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US
Phone
603-603-6038
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PULSAR GENERATORGENERATOR,ELECTROSURGICAL,COAGULATION,CANCERMEDTRONIC ADVANCED ENERGY, LLCMULMAE UNK PEAK GENMAE UNK PEAK GENN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-170

Event Narratives#

D

Patient 1

DURING A TONSIL AND ADENOIDECTOMY CASE THE PLASMABLADE TNA DEVICE (ADENOID TIP) SPARKED. THE GENERATOR SETTINGS AT THE TIME OF THE SPARK WERE COAG 8, CUT 1, BUT THE OXYGEN SETTING WAS UNKNOWN. NO PATIENT IMPACT (PATIENT DETAILS REFUSED TO BE GIVEN BY USER FACILITY). *DUE TO THE FACT THAT THE GENERATOR COULD NOT BE RULED OUT AS THE CAUSE OR A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT IT IS DEEMED REPORTABLE

N

Patient 1

PRODUCT EVENT (B)(4). METHOD, RESULTS, CONCLUSION: GENERATOR NOT RETURNED THEREFORE ANALYSIS UNABLE TO BE PERFORMED. (B)(4).

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.