BOVIE MEDICAL
Report
- Report Number
- 3007208013-2024-00037
- Event Type
- Malfunction
- Date Received
- August 2, 2024
- Date of Event
- July 10, 2024
- Report Date
- September 13, 2024
- Manufacturer
- BOVIE MEDICAL CORP.
- Product Code
- HQP
- UDI-DI
- 00607151011017
- PMA / PMN Number
- K121441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AWAITING ADDITIONAL INFORMATION AND/OR RETURN OF THE REPORTED DEVICE TO COMPLETE THE EVALUATION. SUPPLEMENTAL REPORT 001 - UPDATED BLOCK H10 PER FDA REQUEST.
THE COMPLAINT WAS ABLE TO BE CONFIRMED BASED ON THE INFORMATION PROVIDED IN THE MEDWATCH REPORT. ROOT CAUSE IS DETERMINED TO BE USER ERROR IN HANDLING OF DEVICE: PER THE DEVICE'S IFU (MC-23009 REV 10) - 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 - CAUTERY TIP WILL REMAIN HOT IMMEDIATELY AFTER DEACTIVATION AND MAY CAUSE INADVERTENT BURNS TO USER OR PATIENT. - ALWAYS RETAIN THE COVER CAP AND REPLACE IT ON THE CAUTERY WHEN NOT IN USE. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.
AWAITING ADDITIONAL INFORMATION AND/OR RETURN OF THE REPORTED DEVICE TO COMPLETE THE EVALUATION.
RECEIVED VIA FDA'S MEDSUN PROGRAM (REPORT NUMBER: (B)(4)). THE COMPLAINANT ALLEGES, "DURING A PEDIATRIC SURGERY, THE PATIENT WAS MASKED DOWN FOR A LYSIS OF PENILE ADHESION. WHEN THE SURGEON USED THE CAUTERY HIGH TEMP FINE TIP BOVIE IT TOOK A MINUTE TO ACTIVATE AND HEAT UP. ONCE IT WARMED UP ENOUGH, THE SURGEON STARTED THE PROCEDURE. THE FIRST ASSIST STUDENT NOTICED THE RAYTEC SPONGE IN THEIR HAND STARTED TURNING BLACK AND FELT WARM. THEY PLACED THE RAYTEC ON THE MAYO STAND AND AN EMBER FORMED AND CAUGHT ON FIRE. THE SURGICAL TECH TOSSED THE RAYTEC ON THE FLOOR TO AVOID FURTHER SPREAD. THE FIRE WAS THEM PUT OUT SAFELY WITH NO HARM TO THE PATIENT OR OTHERS."
RECEIVED VIA FDA'S MEDSUN PROGRAM (REPORT NUMBER: (B)(4)). THE COMPLAINANT ALLEGES, "DURING A PEDIATRIC SURGERY, THE PATIENT WAS MASKED DOWN FOR A LYSIS OF PENILE ADHESION. WHEN THE SURGEON USED THE CAUTERY HIGH TEMP FINE TIP BOVIE IT TOOK A MINUTE TO ACTIVATE AND HEAT UP. ONCE IT WARMED UP ENOUGH, THE SURGEON STARTED THE PROCEDURE. THE FIRST ASSIST STUDENT NOTICED THE RAYTEC SPONGE IN THEIR HAND STARTED TURNING BLACK AND FELT WARM. THEY PLACED THE RAYTEC ON THE MAYO STAND AND AN EMBER FORMED AND CAUGHT ON FIRE. THE SURGICAL TECH TOSSED THE RAYTEC ON THE FLOOR TO AVOID FURTHER SPREAD. THE FIRE WAS THEM PUT OUT SAFELY WITH NO HARM TO THE PATIENT OR OTHERS."
RECEIVED VIA FDA'S MEDSUN PROGRAM (REPORT NUMBER: (B)(4)). THE COMPLAINANT ALLEGES, "DURING A PEDIATRIC SURGERY, THE PATIENT WAS MASKED DOWN FOR A LYSIS OF PENILE ADHESION. WHEN THE SURGEON USED THE CAUTERY HIGH TEMP FINE TIP BOVIE IT TOOK A MINUTE TO ACTIVATE AND HEAT UP. ONCE IT WARMED UP ENOUGH, THE SURGEON STARTED THE PROCEDURE. THE FIRST ASSIST STUDENT NOTICED THE RAYTEC SPONGE IN THEIR HAND STARTED TURNING BLACK AND FELT WARM. THEY PLACED THE RAYTEC ON THE MAYO STAND AND AN EMBER FORMED AND CAUGHT ON FIRE. THE SURGICAL TECH TOSSED THE RAYTEC ON THE FLOOR TO AVOID FURTHER SPREAD. THE FIRE WAS THEM PUT OUT SAFELY WITH NO HARM TO THE PATIENT OR OTHERS.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 985115 | BOVIE MEDICAL | CAUTERY | HQP | BOVIE MEDICAL CORP. | AA01 | 0322Z | 00607151011017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |