NA 5407-300-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327177367), received between Dec 8, 2021 and May 28, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Overheating 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 25313241 ↗
• MalfunctionAug 15, 2025Overheating 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 22818732 ↗
• MalfunctionJul 11, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED AT THE USER FACILITY. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478782 ↗
• MalfunctionJul 10, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED AT THE USER FACILITY. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468141 ↗
• MalfunctionJul 10, 2025Overheating 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 22468130 ↗
• MalfunctionJul 10, 2025Overheating 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 22468128 ↗
• MalfunctionJul 9, 2025Overheating 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 22461000 ↗
• MalfunctionJul 9, 2025Overheating 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 22460996 ↗
• MalfunctionJul 9, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456709 ↗
• MalfunctionAug 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE SHAFT FELL OUT DURING SETUP 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 20103829 ↗
• MalfunctionAug 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE SHAFT FELL OUT DURING SETUP 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 20103828 ↗
• MalfunctionOct 17, 2023Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952885 ↗
• MalfunctionMar 1, 2023Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458811 ↗
• MalfunctionDec 15, 2022Overheating 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 15985681 ↗
• MalfunctionDec 15, 2022Overheating 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 15985621 ↗
• MalfunctionDec 15, 2022Overheating 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 15985617 ↗
• MalfunctionDec 8, 2021Overheating of Device; Overheating of Device

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE 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 12962332 ↗