N/A 6700-313-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327303889), received between Nov 7, 2018 and Aug 26, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Intermittent Energy Output” (18 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WAS INTERMITTENTLY DELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897210 ↗
• MalfunctionApr 24, 2025Output above Specifications; Intermittent Energy Output; Output above Specifications; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE ENERGY WAS OUT OF TOLERANCE DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900499 ↗
• MalfunctionMar 20, 2025Intermittent Energy Output; Intermittent Energy Output

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657872 ↗
• MalfunctionDec 18, 2024Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WAS UNDERDELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968506 ↗
• MalfunctionOct 8, 2024Output above Specifications; Output above Specifications

  A MANUFACTURER SALES REPRESENTATIVE REPORTED THE DEVICE WAS OVER DELIVERING ENERGY DURING USE IN A PROCEDURE AT THE USER FACILITY, A CONDITION WHICH MAY POSE THE RISK OF TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396347 ↗
• MalfunctionMay 7, 2024Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THAT THE DEVICE HAD INCONSISTENT OUTPUT DURING A PROCEDURE, A CONDITION IN WHICH THE DEVICE MAY OVERDELIVER OR UNDERDELIVER ENERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262440 ↗
• MalfunctionApr 16, 2024Output below Specifications; Intermittent Energy Output; Output below Specifications; Intermittent Energy Output

  THE USER FACILITY REPORTED THAT THE DEVICE HAD INCONSISTENT OUTPUT DURING A PROCEDURE, A CONDITION IN WHICH THE DEVICE MAY OVERDELIVER OR UNDERDELIVER ENERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122591 ↗
• MalfunctionMar 20, 2024Output below Specifications; Output below Specifications

  THE USER FACILITY REPORTED THE DEVICE WAS UNDERDELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943743 ↗
• MalfunctionJan 10, 2024Output above Specifications; Output above Specifications

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THE DEVICE WAS OVERDELIVERING ENERGY, A CONDITION WHICH MAY POSE AN INCREASED RISK OF TISSUE DAMAGE, DURING TESTING AT THE CONTRACT MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489625 ↗
• MalfunctionDec 21, 2023Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE HAD INCONSISTENT ENERGY OUTPUT, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377198 ↗
• MalfunctionDec 13, 2023Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THAT THE DEVICE HAD INCONSISTENT FUNCTIONALITY DURING A PROCEDURE, A CONDITION IN WHICH THE DEVICE MAY OVERDELIVER OR UNDERDELIVER ENERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323240 ↗
• MalfunctionMay 26, 2023Output below Specifications; Output below Specifications

  THE USER FACILITY REPORTED THE DEVICE WAS UNDERDELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17013827 ↗
• MalfunctionAug 22, 2022Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WAS UNDERDELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15270240 ↗
• MalfunctionApr 29, 2022Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS UNDER DELIVERING ENERGY, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254658 ↗
• MalfunctionApr 19, 2022Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THAT THE DEVICE HAD INCONSISTENT OUTPUT DURING A PROCEDURE, A CONDITION IN WHICH THE DEVICE MAY UNDERDELIVER ENERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141961 ↗
• MalfunctionFeb 25, 2022Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WAS UNDER DELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606113 ↗
• MalfunctionFeb 25, 2022Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WAS UNDER DELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13605835 ↗
• MalfunctionJan 31, 2022Intermittent Loss of Power; Intermittent Energy Output; Intermittent Loss of Power; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WOULD SHUT DOWN DURING USE AND SOMETIMES COULD NOT BE POWERED BACK ON, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392826 ↗
• MalfunctionJan 20, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE USER FACILITY REPORTED THE DEVICE WAS UNDER DELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310895 ↗
• MalfunctionMay 28, 2021Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE WAS UNDER DELIVERING ENERGY AT HIGHER SETTINGS DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901652 ↗
• MalfunctionMay 10, 2021Energy Output Problem; Energy Output Problem

  THE USER FACILITY REPORTED THE DEVICE WAS OVER DELIVERING ENERGY DURING A PROCEDURE, A CONDITION WHICH MAY POSE AN INCREASED RISK OF TISSUE DAMAGE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11801395 ↗
• MalfunctionMar 31, 2021Intermittent Energy Output; Intermittent Energy Output

  THE USER FACILITY REPORTED THE DEVICE HAD INTERMITTENT ENERGY OUTPUT DURING A PROCEDURE, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595575 ↗
• MalfunctionMar 15, 2021Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING TESTING BY THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY, THE DEVICE HAD INTERMITTENT ENERGY OUTPUT, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483413 ↗
• MalfunctionNov 18, 2020Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE HAD INTERMITTENT ENERGY OUTPUT, A CONDITION WHICH MAY POSE THE RISK OF INSUFFICIENT COAGULATION AND INCREASED BLEEDING. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10862795 ↗
• MalfunctionApr 26, 2019Energy Output Problem; Energy Output Problem

  THE USER FACILITY REPORTED THAT THE DEVICE HAD INTERMITTENT OUTPUT DURING A PROCEDURE, A CONDITION IN WHICH THE DEVICE MAY OVERDELIVER OR UNDERDELIVER ENERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556848 ↗