Medline 0118RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277377950), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJul 18, 2025Failure to Disconnect; Detachment of Device or Device Component; Human-Device Interface Problem; Failure to Disconnect; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; PATIENT RECEIVED BURNS ON INNER AND OUTER MOUTH FROM CAUTERY. A NEEDLE TIP BOVIE WAS USED AND PATIENT WAS GROUNDED ON LEFT LATERAL THIGH WITH BOVIE PAD. SURGEON NOTICED THAT BOVIE TIP WASN'T PROPERLY INSULATED AND THAT A PART OF THE INSULATED PORTION WAS MISSING, HOWEVER THE BURNS SEEM TO COME FROM THE WHITE INSULATED PART OF THE BOVIE PENCIL THAT WAS RESTING ON THE PATIENT LIP IN BETWEEN USES. IT WOULD SEEM THAT THERE WAS A MALFUNCTION WITH THE BOVIE PENCIL ITSELF BECAUSE UPON CHANGING THE BOVIE TIP THE SAME ISSUE REOCCURRED WITH THE PATIENT BEING BURNED AROUND THE MOUTH. AS A RESULT, A NEW BOVIE PENCIL WAS INSTEAD OPENED AND THE ISSUE WAS RESOLVED. AT THE END OF SURGERY NOTICEABLE BURNS WERE NOTED ON INSIDE AND OUTSIDE MOUTH AREAS. AND SURGEON REQUESTED BACITRACIN OINTMENT TO BE APPLIED BEFORE GOING TO PACU. SURGEON WAS INFORMED THAT THE PATIENT HAD SUSTAINED BURNS ON INNER AND OUTER MOUTH FROM ELECTROCAUTERY PENCIL. THE SURGEON NOTICED THAT THE NEEDLE TIP BOVIE WAS NOT PROPERLY INSULATED AND SOME PARTS WERE MISSING. A NEW PENCIL WAS PROVIDED AND THE ISSUE WAS RESOLVED. THE MALFUNCTIONING PIECES WERE SAVED AND PICTURES WERE TAKEN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22545936 ↗