NA 5407-NFA-8CMRecalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 07613327277517), received between Jul 24, 2018 and Apr 22, 2026 — classified as 89 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (36 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. 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 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 12 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 11 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953801 ↗
• MalfunctionJan 23, 2026Flaked

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164002 ↗
• MalfunctionJan 23, 2026Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163435 ↗
• MalfunctionOct 23, 2025Flaked; Flaked

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369148 ↗
• MalfunctionOct 23, 2025Overheating of Device; Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369128 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648127 ↗
• MalfunctionJul 24, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. - 2 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587055 ↗
• MalfunctionJul 24, 2025Flaked; Flaked

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 7 EVENTS FOR THE FAILURE: FLAKED. - 7 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586855 ↗
• MalfunctionApr 21, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 16 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 16 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876820 ↗
• MalfunctionApr 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 5 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876639 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876603 ↗
• MalfunctionApr 21, 2025Fracture; Overheating of Device; Fracture; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED AND REPORTEDLY OVERHEATED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875709 ↗
• MalfunctionJan 22, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 3 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207527 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. -THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207524 ↗
• MalfunctionJan 21, 2025Flaked; Flaked

  THIS REPORT SUMMARIZES 16 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 16 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201024 ↗
• MalfunctionOct 29, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560358 ↗
• MalfunctionOct 29, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560246 ↗
• MalfunctionOct 22, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 15 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 15 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501803 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - (B)(4) EVENTS HAD NO PATIENT INVOLVEMENT, NO PATIENT IMPACT. - (B)(4) EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT. - (B)(4) EVENT WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500137 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 14 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 13 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823115 ↗
• MalfunctionJul 24, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 28 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. - 28 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822839 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 20 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 13 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 7 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113524 ↗
• MalfunctionApr 16, 2024Flaked; Flaked

  THIS REPORT SUMMARIZES 17 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD PAINT CHIPS MISSING. 17 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113518 ↗
• MalfunctionJan 22, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 8 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557730 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556901 ↗