NA 5100120450Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04546540369956), received between Jul 24, 2018 and Oct 2, 2023 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (50 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. PATIENT INVOLVEMENT WAS NOT REPORTED AT THIS TIME.

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

  MAUDE report 17855556 ↗
• MalfunctionSep 25, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 17813722 ↗
• MalfunctionJun 6, 2022Overheating 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 14604712 ↗
• MalfunctionApr 21, 2022Overheating 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 14169951 ↗
• MalfunctionApr 13, 2022Overheating 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 14106528 ↗
• MalfunctionOct 6, 2021Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586543 ↗
• MalfunctionJun 16, 2021Overheating 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 12012527 ↗
• MalfunctionJun 16, 2021Overheating 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 12012480 ↗
• MalfunctionJun 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 11961030 ↗
• MalfunctionApr 29, 2021Overheating 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 11747098 ↗
• MalfunctionApr 29, 2021Overheating 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 11747092 ↗
• MalfunctionApr 7, 2021Overheating of Device; Overheating of Device

  THE MANUFACTURER REPRESENTATIVE 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 11628816 ↗
• MalfunctionFeb 25, 2021Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379873 ↗
• MalfunctionNov 17, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED DURING A DEMO VISIT AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10854293 ↗
• MalfunctionNov 13, 2020Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10836881 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A FRACTURED FOOT. THE EVENT OCCURRED DURING FUNCTIONAL TESTING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693219 ↗
• MalfunctionOct 1, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE WAS OVERHEATING DURING TESTING CONDUCTED AT THE USER FACILITY. THE USER FACILITY REPORTED THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10614026 ↗
• MalfunctionAug 20, 2020Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10434250 ↗
• MalfunctionJul 31, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED. THE EVENT OCCURRED DURING FUNCTIONAL TESTING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

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

  MAUDE report 10350104 ↗
• MalfunctionApr 14, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER 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; No Patient Involvement

  MAUDE report 9957180 ↗
• MalfunctionMar 31, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER 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; No Patient Involvement

  MAUDE report 9907831 ↗
• MalfunctionMar 31, 2020Overheating 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; No Patient Involvement

  MAUDE report 9907826 ↗
• MalfunctionMar 31, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER 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; No Patient Involvement

  MAUDE report 9907818 ↗
• MalfunctionMar 23, 2020Overheating 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 Patient Involvement

  MAUDE report 9867898 ↗
• MalfunctionMar 23, 2020Overheating 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 Patient Involvement

  MAUDE report 9867886 ↗