DrillCut-X 40712050Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04048551253632), received between Sep 20, 2023 and Sep 29, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940916 ↗
• MalfunctionAug 17, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50282091 ↗
• MalfunctionAug 17, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50281746 ↗
• MalfunctionJul 27, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008569 ↗
• MalfunctionFeb 10, 2026Output Problem

  THE FOLLOWING WAS REPORTED: "ERROR CODE E19". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24310571 ↗
• MalfunctionJan 9, 2026Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT "ERROR CODE "E19"". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020590 ↗
• MalfunctionJan 5, 2026Electrical /Electronic Property Problem; No Device Output

  IT WAS REPORTED THAT "NOT WORKING". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960079 ↗
• MalfunctionDec 19, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "DEVICE IS GETTING STUCK DURING THE USAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858111 ↗
• MalfunctionOct 17, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT "BLOCKED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323579 ↗
• MalfunctionAug 11, 2025Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  IT WAS REPORTED THAT PRIOR THE PATIENT WAS ROLLED INTO THE OR FOR A SMRT PROCEDURE ON (B)(6) 2025, THE DEVICE STOPPED WORKING WHEN THE PEDAL WAS PRESSED. THEY HAD TO POSTPONE THE PROCEDURE, GET A BACK-UP DEVICE, AND THEN COMPLETE THE PROCEDURE LATER THE SAME DAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773494 ↗
• InjuryAug 11, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT PRIOR THE PATIENT WAS ROLLED INTO THE OR FOR A SMRT PROCEDURE ON (B)(6) 2025, THE DEVICE STOPPED WORKING WHEN THE PEDAL WAS PRESSED. THEY HAD TO POSTPONE THE PROCEDURE, GET A BACK-UP DEVICE, AND THEN COMPLETE THE PROCEDURE LATER THE SAME DAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773493 ↗
• MalfunctionAug 4, 2025Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE WAS STUCK. THE PROCEDURE WAS FINISHED WITH A BACKUP DEVICE. THE PROBLEM OCCURRED AT THE BEGINNING OF THE PROCEDURE. THERE WAS NO HART OR SMOKE DEVELOPMENT OF THE DEVICE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701285 ↗
• MalfunctionJun 4, 2025Defective Component; Unexpected Shutdown; Defective Component; Unexpected Shutdown

  ACCORDING TO THE INFORMATION RECEIVED, MOTOR BLOCKED. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144320 ↗
• InjuryJul 19, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCUDURE ON (B)(6) 2023, THE MOTOR FUNCTION ON THE HAND-PIECE STOPPED WORKING. DEVICE DISPLAYED E-19 ERROR MESSAGE (MOTOR MALFUNCTION). THEY WERE UNABLE TO COMPLETE THE PROCEDURE, AND HAD TO RE-SCHEDULE. CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785826 ↗
• MalfunctionOct 11, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A LOCAL BALLOON SINUS DILATION WITH TURBS REDUCTION ON (B)(6) 2023, THE MOTOR FUNCTION ON THE HAND-PIECE STOPPED WORKING. THEY HAD TO MOVE THE PATIENT TO ANOTHER ROOM THAT CARRIED AN ENTELLUS DEBRIDER, WHERE THEY COMPLETED THE PROCEDURE WITH NO PATIENT INJURY. HOWEVER, THIS ISSUE CAUSED THE DR. TO BE BEHIND SCHEDULE FOR ABOUT 30 MINUTES DUE TO MOVING THE PATIENT TO THE OTHER ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916548 ↗
• MalfunctionOct 11, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A LOCAL BALLOON SINUS DILATION WITH TURBS REDUCTION ON (B)(6) 2023, THE MOTOR FUNCTION ON THE HAND-PIECE STOPPED WORKING. THEY HAD TO MOVE THE PATIENT TO ANOTHER ROOM THAT CARRIED AN ENTELLUS DEBRIDER, WHERE THEY COMPLETED THE PROCEDURE WITH NO PATIENT INJURY. HOWEVER, THIS ISSUE CAUSED THE DR. TO BE BEHIND SCHEDULE FOR ABOUT 30 MINUTES DUE TO MOVING THE PATIENT TO THE OTHER ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916541 ↗
• MalfunctionOct 11, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A LOCAL BALLOON SINUS DILATION WITH TURBS REDUCTION ON (B)(6) 2023, THE MOTOR FUNCTION ON THE HAND-PIECE STOPPED WORKING. THEY HAD TO MOVE THE PATIENT TO ANOTHER ROOM THAT CARRIED AN ENTELLUS DEBRIDER, WHERE THEY COMPLETED THE PROCEDURE WITH NO PATIENT INJURY. HOWEVER, THIS ISSUE CAUSED THE DR. TO BE BEHIND SCHEDULE FOR ABOUT 30 MINUTES DUE TO MOVING THE PATIENT TO THE OTHER ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916540 ↗
• InjurySep 20, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCUDURE ON (B)(6) 2023, THE MOTOR FUNCTION ON THE HAND-PIECE STOPPED WORKING. DEVICE DISPLAYED E-19 ERROR MESSAGE (MOTOR MALFUNCTION). THEY WERE UNABLE TO COMPLETE THE PROCEDURE, AND HAD TO RE-SCHEDULE. CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784687 ↗