SURGAIRTOME TWO 00505800100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20845854018924), received between Mar 4, 2022 and Dec 18, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K781979); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Overheating of Device; Overheating of Device

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00505800100, SURGAIRTOME TWO HANDPIECE, WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2023, AND THE ¿OVERHEATED SURGAIRTOME RESULTED IN A BURN TO THE PATIENTS INNER LIP¿. THE CUSTOMER CONFIRMED ¿IT WAS A FIRST DEGREE BURN. THEY TREATED IT WITH OINTMENT, NO SURGICAL INTERVENTION. THE PATIENT IS CURRENTLY ¿OK¿. THE SURGERY WAS COMPLETED SUCCESSFULLY.¿. THE 00137501200 WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18344277 ↗
• MalfunctionMar 4, 2022Break

  A BURR SNAPPED IN HALF AT THE STERILE FIELD DURING SURGERY DUE TO A BROKEN LOCKING MECHANISM ON A SURGAIRTOME.

  Patient problems: Insufficient Information

  MAUDE report 13666307 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K781979. One submission often covers many models, so check the product and lot details in each record.

• Z-0711-2008 · Aug 9, 2007 · Terminated
  ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773
• Z-0041-05 · Aug 26, 2004 · Terminated
  Ultra Power Burs, Sterile, Single-Use.