BoneScalpel MXB-MIS-S1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626101999), received between Dec 12, 2018 and Dec 12, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Temperature Problem” (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 18, 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.

• InjuryDec 12, 2018Temperature Problem; Temperature Problem

  CUSTOMER STATED PROBLEM AS "THE DISPOSABLE HEATED UP TO THE POINT OF CREATING A THERMAL BURN THROUGH THE BLACK CONE ON OPEN TISSUE DURING THE CASE. THE TISSUE WAS AN ASHY BLACK COLOR AFTERWARD. THE BLACK NOSE CONE DIDN'T SHOW SIGNED OF MELTING."

  Patient problems: Burn, Thermal

  MAUDE report 8158065 ↗