NA 5100010472Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540348449), received between Oct 29, 2018 and Feb 17, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2021Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340007 ↗
• MalfunctionDec 8, 2020Overheating of Device; Overheating of Device

  THE DISTRIBUTOR REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969323 ↗
• MalfunctionSep 25, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10587866 ↗
• MalfunctionDec 5, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED DURING TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8135668 ↗
• MalfunctionDec 5, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED DURING TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8135659 ↗
• MalfunctionOct 29, 2018Overheating 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 8013993 ↗