BOVIE MEDICAL
Report
- Report Number
- 3007208013-2024-00033
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Report Date
- September 13, 2024
- Manufacturer
- BOVIE MEDICAL CORP.
- Product Code
- HQP
- UDI-DI
- 00607151011031
- PMA / PMN Number
- K121441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AWAITING ADDITIONAL INFORMATION AND/OR RETURN OF THE REPORTED DEVICE TO COMPLETE THE EVALUATION.
PER THE CUSTOMER, THE CUSTOMER WAS COMPLETING A NAIL TREPHINATION, WHEN THE CAUTERY WAS HEATED FOR A FEW SECONDS, THE WIRE BROKE NEAR THE TIP. IN THE FIRST INCIDENT, THE WIRE MELTED TO THE PATIENT'S NAIL, BUT WAS ABLE TO BE EASILY REMOVED. THE FIRST CAUSE TIP BROKE WHILE TOUCHING PATIENT NAIL. THE NEXT TWO CAUTEY TIPS BROKE WITH NOT TOUCHING ANYTHING. THE COMPLAINT WAS UNABLE TO BE CONFIRMED AS THE PRODUCT WAS UNABLE TO BE RETURNED FOR TESTING AND PICTURES WERE UNAVAILABLE. TRUE ROOT CAUSE IS UNABLE TO BE DETERMINED WITH ACCURACY AT THIS TIME. 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.
THE COMPLAINANT ALLEGES, "THE AA03 WITH LOT 0923Y HAD THE TIP AT THE END BREAK DURING USE. NO PATIENT INVOLVEMENT."
THE COMPLAINANT ALLEGES, "THE AA03 WITH LOT 0923Y HAD THE TIP AT THE END BREAK DURING USE. NO PATIENT INVOLVEMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446630 | BOVIE MEDICAL | CAUTERY | HQP | BOVIE MEDICAL CORP. | AA03 | 0923Y | 00607151011031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |