FDA.reportPublic FDA data

MAUDE MDR 7718415

MDR report key
7718415
Report number
3007593903-2018-00039
Event key
0
Event type
3
Date received
2018-07-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. DANNELLE LAO
Address
5115 ULMERTON ROAD CLEARWATER FL 33760 US
Phone
727-727-7278
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BOVIE MEDICALAA21BOVIE MEDICAL CORPORATIONHQPAA21AA21R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-250

Event Narratives#

N

Patient 1

BOVIE MEDICAL RECEIVED A MEDWATCH REPORT MW5078136 IN WHICH A REPORTED COMPLAINT THAT ALLEGED THAT THE TIP OF A CAUTERY FLEW AND CAUSED A FIRE WITH A GAUZE. THE INFORMATION PROVIDED ALLEGED THAT THE FIRE WAS EXTINGUISHED AND THERE WERE NO PATIENT OR USER INJURY. ONLY A TYPE OF PROCEDURE AND THE ISSUE WAS PROVIDED TO BOVIE. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE MEDWATCH REPORT MATCHES WITH A REPORTED COMPLAINT FOR A SIMILAR EVENT. BOVIE MEDICAL COMPLETED AN EVALUATION OF THE REPORTED COMPLAINT AND DETERMINED THAT THE COMPLAINT DID NOT MEET THE REPORTABILITY CRITERIA. THE TIPS ARE DESIGNED TO CUT SOFT TISSUE. THE CAUTERY TIP REACHES THE EXTREME TEMPERATURE TO ACHIEVE THE INTENDED USE. THE EXTREME TEMPERATURE WILL CREATE A REDUCTION IN THE STRUCTURAL STRENGTH OF THE WIRE OF THE TIP. AT THE EXTREME TEMPERATURE AND CORRESPONDING REDUCTION IN STRUCTURAL STRENGTH, IT IS POSSIBLE THAT THE TIP WILL BREAK IF EXCESSIVE PRESSURE IS APPLIED. IT SHOULD BE NOTED THAT THE MINUTE THE TIP BREAKS AND THE TIP LOOSES POWER THE TEMPERATURE WILL IMMEDIATELY REDUCE TO A TEMPERATURE THAT THE TIPS STRUCTURAL STRENGTH RETURNS. IT IS EXTREMELY UNLIKELY THAT THE TIP WILL BREAK IN MORE THAN ONE LOCATION DUE TO THE IMMEDIATE LOSS IN POWER AND TEMPERATURE. SEVERITY: NEGLIGIBLE (NO ADVERSE HEALTH CONSEQUENCE OR CLINICALLY INSIGNIFICANT ADVERSE HEALTH CONSEQUENCE; OR CLINICALLY INSIGNIFICANT PROLONGATION OR DELAY OF THE PROCEDURE WITH NO ADVERSE HEALTH CONSEQUENCE, TEMPORARY DISCOMFORT, INCONVENIENCE). OCCURRENCE: UNLIKELY - MISUSE OF THE PRODUCT. BOVIE MEDICAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND CAUTIONS REGARDING THE USE OF THE DEVICE IN THE PROXIMITY OF FLAMMABLE AGENTS. THE FOLLOWING WARNINGS ARE INCLUDED IN THE IFU: DO NOT USE IN THE PRESENCE OF FLAMMABLE GASES/MATERIALS OR IN OXYGEN RICH ENVIRONMENTS. FIRE COULD RESULT. CAUTERY PRODUCES HEAT IN EXCESS OF 1000 DEGREES F, WHICH CAN CAUSE BURNS OR FIRE FROM MISUSE. REPORTED COMPLAINT WAS NOT CONFIRMED, NO ADDITIONAL INFORMATION WAS PROVIDED AND THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

D

Patient 1

THE REPORTED COMPLAINT ALLEGED THAT DURING A CYST PROCEDURE, A TIP OF THE CAUTERY SIZZLED AND FLEW OFF. AT THE SAME TIME, THE GAUZE CAUGHT ON FIRE. NO PATIENT INJURY RESULTED FROM THE EVENT.