BoneScalpel BCM-HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626100688), received between Apr 23, 2021 and Apr 23, 2021 — 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.

• MalfunctionApr 23, 2021Overheating of Device; Overheating of Device

  (B)(6) REPRESENTATIVE, (B)(6), PROVIDED A TRANSLATED INCIDENT REPORT TO MISONIX ON 03/25/2021. "POWER ON OF THE MISONIX BONESCALPEL HAND PIECE, AFTER HAVING PURGED THE IRRIGATION TUBING, THE HANDPIECE STARTED TO HEAT UP, BURNING THE SURGEON WHO WAS HOLDING IT, FORCING HIM TO PUT DOWN THE HAND PIECE WHICH STARTED TO MELT AND RELEASE SMOKE."

  Patient problems: Insufficient Information

  MAUDE report 11720146 ↗