Olympus WA91327URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761087698), received between Feb 11, 2025 and May 15, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jul 25, 2025Open, Classified

   Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

   Z-2338-2025 · Root cause: Component change control · FDA record ↗

2. Sep 4, 2024Open, Classified

   There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

   Z-0264-2025 · Root cause: Software design · FDA record ↗

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.

• MalfunctionMay 15, 2025Circuit Failure; Circuit Failure

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR EXHIBITED THE HIGH VOLTAGE POWER SUPPLY BOARD HAD BLOWN CAPACITOR. AFTER REPLACING THE HIGH VOLTAGE POWER SUPPLY BOARD AND FUSES THE UNIT FAILED SELF-TEST WITH AN ERROR 0432. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023844 ↗
• InjuryFeb 11, 2025Activation Failure; Activation Failure

  IT WAS REPORTED WHEN USING THE GENERATOR WITH A THUNDERBEAT HANDPIECE, THERE WAS NO ACTIVATION. THE ISSUE OCCURRED DURING A SLEEVE GASTRECTOMY PROCEDURE WHILE THE PATIENT WAS SEDATED. THE USER CONNECTED A BOVIE PENCIL AND BOVIE PAD AND HAD THE SAME ISSUE. THE GENERATOR GAVE AN E0728 SYSTEM ERROR AND AN E1809 NEUTRAL ELECTRODE DISCONNECTED ERROR. THE USER TRIED ANOTHER PAD AND ELECTRODE, BUT THE DEVICE CONTINUED TO ERROR. THE PROCEDURE WAS COMPLETED WITH MANUAL OVER SEWING AND WAS PROLONGED GREATER THAN 30 MINUTES. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359549 ↗
• InjuryFeb 11, 2025Activation Failure; Activation Failure

  IT WAS REPORTED WHEN USING THE GENERATOR WITH A THUNDERBEAT HANDPIECE, THERE WAS NO ACTIVATION. THE ISSUE OCCURRED DURING A SLEEVE GASTRECTOMY PROCEDURE WHILE THE PATIENT WAS SEDATED. THE USER CONNECTED A BOVIE PENCIL AND BOVIE PAD AND HAD THE SAME ISSUE. THE GENERATOR GAVE AN E0728 SYSTEM ERROR AND AN E1809 NEUTRAL ELECTRODE DISCONNECTED ERROR. THE USER TRIED ANOTHER PAD AND ELECTRODE, BUT THE DEVICE CONTINUED TO ERROR. THE PROCEDURE WAS COMPLETED WITH MANUAL OVER SEWING AND WAS PROLONGED GREATER THAN 30 MINUTES. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359460 ↗