Ultrasonic Generator USG-400 (REF N5428140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170386817), received between Sep 11, 2018 and May 1, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945176 ↗
• InjuryMay 1, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION TO B2. B2 SHOULD HAVE HAD REQUIRED INTERVENTION CHECKED INSTEAD OF OTHER SERIOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945136 ↗
• InjuryOct 14, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A LAPACOLLE SURGERY, AN OVERCURRENT ERROR U010 OCCURRED WHEN USING THE SUBJECT DEVICE. THE PROCEDURE AND PATIENT'S ANESTHESIA WERE EXTENDED BY 30 MINUTES TO DEAL WITH THE ERRORS AS IT OCCURRED MULTIPLE TIMES AND TO REPLACE THE TRANSDUCER. THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. NO ADDITIONAL MEDICATION WAS ADMINISTERED, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446565 ↗
• InjurySep 11, 2018Output above Specifications; Output above Specifications

  THE 2 OF 3. OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE INVOLVING AN UNKNOWN MODEL OLYMPUS GENERATOR AND UNKNOWN MODEL OLYMPUS THUNDERBEAT DEVICE, THE PATIENT HAD A LIVER BURN INJURY. IT WAS REPORTED THAT THE CUT AND COAG OUTPUT WAS TOO HIGH, LEADING TO THE THUNDERBEAT HANDPIECE OVERHEATING AND BURNING THE PATIENT¿S LIVER. THIS COMPLAINT ADDRESSES THE SECOND OF TWO POSSIBLE GENERATOR MODELS REPORTED FOR THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 7867159 ↗