MICRO-LINE GB109Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653241132), received between Dec 5, 2020 and Dec 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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.

• MalfunctionDec 5, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED TO AESCULAP AG THAT A MICROLINE STRAIGHT HANDPIECE (PART # GB109) WAS USED DURING AN ORAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE DEVICE GENERATED HEAT WHEN USED IN COMBINATION WITH ANOTHER MANUFACTURERS BAR. REPORTEDLY, A LARGE SWOLLEN BURN OCCURRED ON THE BACK OF THE PATIENT'S LIPS. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Burn(s)

  MAUDE report 10952337 ↗