Bovie ESRECRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607151563530), received between Oct 7, 2022 and Oct 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2022Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER ALLEGED: "1. WE ARE DOING QUALITY REVIEW OF THE PATIENT ISSUE WITH THE LEEP MACHINE. WHEN THE PROBE WAS PLACED INTO THE VAGINAL CANAL, PRIOR TO TOUCHING ANY TISSUE, IT ARCED AND CAUSED A BURN TO THE PATIENTS UTERUS. WHEN INVESTIGATING I FOUND THE GROUNDING PAD USED MFR22-ESREC WAS EXPIRED. QUALITY IS ASKING FOR CONFIRMATION FROM THE COMPANY THAT EXPIRED PADS COULD CAUSE THIS TYPE OF ISSUE. OTHERWISE, I MAY HAVE TO SEND THE MACHINE IN TO BE CHECKED (AGAIN - IT'S BEEN IN TWICE AND FOUND TO BE FINE)."

  Patient problems: Burn(s)

  MAUDE report 15565809 ↗