Ultrasonic Generator USG-400 (UDI 04953170306754)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170306754), received between Dec 23, 2019 and Nov 6, 2024 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024No Device Output; No Device Output

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620477 ↗
• MalfunctionJan 5, 2023Break; Energy Output Problem; Break; Energy Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING TOTAL THYROIDECTOMY PROCEDURE, THERE WAS A MALFUNCTION OF THE THUNDERBEAT AND THE SEALING WAS TOO SLOW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IN ADDITION, IT WAS REPORTED THAT THE SCREEN OF THE ULTRASOUND GENERATOR IS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109181 ↗
• DeathAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A PANCREATICODUODENECTOMY USING THE SUBJECT DEVICE THE FOLLOWING EVENT OCCURRED. AN UNSPECIFIED ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. ON (B)(6) 2021, WE RECEIVED THE FOLLOWING COMMENT FROM THE DOCTOR. THE DEVICE WAS EASY TO SCAB DURING USE, WHICH CAUSED THE BLOOD VESSELS TO CLOT AT THAT TIME, AND THEN THE SCAB FELL OFF AND THE PATIENT OCCURRED ABDOMINAL(SMALL MESENTERIC BLOOD VESSELS) OCCURRED BLEEDING. IT WILL BE PERFORMED SURGERY AGAIN TO STOP THE BLEEDING. THE PATIENT DIED FINALLY OF EXCESSIVE POSTOPERATIVE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12311392 ↗
• MalfunctionJan 9, 2020Unexpected Shutdown; Unexpected Shutdown

  DURING AN EXCISION OF CAROTID BODY TUMOR, THE SUBJECT DEVICE WAS USED. THE SUBJECT DEVICE MADE ALARM AND REBOOTED ITSELF THREE TIMES. THERE WAS ANOTHER AVAILABLE DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE EXCHANGE OF THE GENERATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9567600 ↗
• MalfunctionDec 23, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT: DURING AN EXTENSIVE HYSTERECTOMY PLUS PELVIC LYMPH NODE DISSECTION, THE SUBJECT DEVICE WAS USED. THE OPERATION PANEL DISPLAY OF THE DEVICE DISAPPEARED AND THE DEVICE RESTARTED AUTOMATICALLY. THE PHYSICIAN STOPPED USING THE DEVICE IMMEDIATELY, THEN, COMPLETED THE PROCEDURE WITH A SIMILAR MEDICAL DEVICE. BLEEDING INCREASED DURING THIS PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9514233 ↗