NA 5450840000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327291933), received between Aug 21, 2018 and Jul 26, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401357 ↗
• MalfunctionJan 29, 2023Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16262075 ↗
• MalfunctionJul 26, 2022Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108023 ↗
• MalfunctionJul 21, 2021Inability to Irrigate; Overheating of Device; Inability to Irrigate; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING AND OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204185 ↗
• MalfunctionApr 26, 2021Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729115 ↗
• MalfunctionJan 22, 2021Inability to Irrigate; Inability to Irrigate

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11218295 ↗
• MalfunctionJul 27, 2020Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10329763 ↗
• MalfunctionOct 28, 2019Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES NOE 1 / NOE MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9245239 ↗
• MalfunctionApr 24, 2019Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN PATIENT IMPACT OR CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546070 ↗
• MalfunctionJan 29, 2019Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285189 ↗
• MalfunctionSep 24, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE HANDPIECE WAS HEATING UP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903147 ↗
• MalfunctionAug 21, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY, THERE WAS NO IRRIGATION. A LACK OF IRRIGATION IN THE DEVICE IS KNOWN TO CAUSE OVERHEATING. THE USER FACILITY REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 7800862 ↗