THUNDERBEAT Transducer TD-TB400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170306778), received between Jul 30, 2020 and Apr 25, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THUNDERBEAT HAD PROBLEMS WITH SLOW CUTTING SEALING POORLY AND GENERATOR GIVING CONSTANT ERROR MESSAGES DUE TO THE THUNDER BEAT TRANSDUCER CABLE IN A LAPAROSCOPIC GENERAL SURGICAL PROCEDURE (THE EXACT PROCEDURE IS NOT KNOWN). THE PROCEDURE WAS SUCCESSFUL, HOWEVER THE PROCEDURE TOOK LONGER DUE TO CONSTANT ERROR MESSAGES. FOLLOW UP INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THERE WERE 62 ERROR MESSAGES IN ONE DAY PREDOMINANTLY U512 AND U504. THE CABLE WAS RECONNECTED, AND THE GENERATOR RESTARTED. IN WHICH 62 ERROR MESSAGES OCCURRED THAT INTERRUPTED AND DELAYED THE PROCEDURE. IT WAS DIFFICULT TO ESTIMATE THE PROCEDURAL DELAY IN MINUTES, BUT IT TOOK A LITTLE OVER HALF AN HOUR AND AT LEAST 30 SECONDS PER ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, AND PATIENT WAS UNHARMED. REPORTEDLY, LOUD ERROR MESSAGES APPEARED ON THE DEVICE, ¿CAUSING THE USER TO KEEP LOOKING AT THE DEVICE TO SEE WHAT THE ERROR MESSAGE AND TOOK SOMEONE OUT OF THEIR CONCENTRATION.¿ NO PRE-EXISTING CONDITIONS WERE KNOWN. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19185307 ↗
• MalfunctionJan 17, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE PROBE OF THE THUNDERBEAT TRANSDUCER WAS NOT WORKING. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184087 ↗
• MalfunctionJul 30, 2020Melted; Melted

  DEVICE 3 OF 3. IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE TISSUE PADS OF BOTH HANDLES OF THE DEVICE MELTED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR HARM OCCURRED. IT WAS NOTED THE DEVICE WAS INSPECTED PRIOR TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343793 ↗