NA 72201520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010656049), received between Jun 13, 2018 and Jul 7, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BARREL ABRADER BLADE BROKE INSIDE THE PATIENT. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946419 ↗
• MalfunctionSep 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE SURGERY WHEN USING THE DEVICE, AFTER CONNECTING THE DEVICE TO THE HANDPIECE, THE CUTTER DOES NOT PROTRUDE BEYOND THE PROTECTION TUBE AND IS THEREFORE UNUSABLE. TO COMPENSATE FOR THE INCIDENT, A SECOND DEVICE OF THE SAME REFERENCE AND DIFFERENT BATCH WAS USED WITHOUT SUCCESS; THEN A THIRD DEVICE OF THE SAME REFERENCE AND A THIRD BATCH ALSO WITHOUT SUCCESS. THE SURGEON CONTINUED THE PROCEDURE MANUALLY USING A CURETTE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9056684 ↗
• MalfunctionAug 14, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WERE PIECES OF METAL FLYING OFF OF THEM WHILE IT WAS BEING USED IN A CASE. NO PATIENT INJURY WAS REPORTED. ALL THE PIECES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7783094 ↗
• MalfunctionJun 13, 2018Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7599350 ↗