Olympus WA91307CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04042761086349), received between Oct 5, 2023 and May 22, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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-2339-2025 · Root cause: Component change control · FDA record ↗

2. Jun 21, 2024Open, Classified

   Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

   Z-2415-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Flare or Flash

  IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE THE MONOPOLAR CORD BEGAN SMOKING AND CAUGHT FIRE WHILE BEING PLUGGED IN TO THE PORT ON THE GENERATOR. NO HARM REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25255542 ↗
• InjuryAug 15, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, THE ELECTROSURGICAL GENERATOR HAD NO ENERGY. BOTH THE WIRED FOOTSWITCH AND WIRELESS FOOTSWITCH WERE ATTEMPTED. THE FOOTSWITCH INDICATOR ON THE DEVICE WAS INDICATING THE FOOTSWITCHES WERE PASSING A SIGNAL BUT THERE WAS NO ENERGY PRESENT. THERE WERE NO ERROR CODES PRESENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THAT TIME. THE CASE WAS SUBSEQUENTLY CANCELLED DUE TO THE EVENT. THE CUSTOMER RECEIVED A REPLACEMENT ELECTROSURGICAL GENERATOR. THE PATIENT WAS THEN BROUGHT BACK FOR A SECOND ATTEMPT PROCEDURE ON (B)(6) 2025 IN WHICH THEY UNDERWENT GENERAL ANESTHESIA AGAIN. THE SECOND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT HARM. IT WAS REPORTED THAT NO TESTING OF THE DEVICE WAS DONE BEFORE THE FIRST PROCEDURE ATTEMPT. THE CUSTOMER PLUGGED THINGS IN AS USUAL AND BEGAN THE CASE. ALL APPEARED NORMAL UNTIL THE PHYSICIAN WAS IN THE PATIENT AND THE ELECTROSURGICAL GENERATOR WOULD NOT FIRE. IT DID NOT RESPOND TO PEDAL STEPS OR RESETS. IT DID NOT RESPOND TO NEW LOOPS. ALL CONNECTIONS WERE CHECKED AND RESET WITHOUT SUCCESS. THUS, THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819404 ↗
• InjuryAug 15, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, THE ELECTROSURGICAL GENERATOR HAD NO ENERGY. BOTH THE WIRED FOOTSWITCH AND WIRELESS FOOTSWITCH WERE ATTEMPTED. THE FOOTSWITCH INDICATOR ON THE DEVICE WAS INDICATING THE FOOTSWITCHES WERE PASSING A SIGNAL BUT THERE WAS NO ENERGY PRESENT. THERE WERE NO ERROR CODES PRESENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THAT TIME. THE CASE WAS SUBSEQUENTLY CANCELLED DUE TO THE EVENT. THE CUSTOMER RECEIVED A REPLACEMENT ELECTROSURGICAL GENERATOR. THE PATIENT WAS THEN BROUGHT BACK FOR A SECOND ATTEMPT PROCEDURE ON (B)(6) 2025, IN WHICH THEY UNDERWENT GENERAL ANESTHESIA AGAIN. THE SECOND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT HARM. IT WAS REPORTED THAT NO TESTING OF THE DEVICE WAS DONE BEFORE THE FIRST PROCEDURE ATTEMPT. THE CUSTOMER PLUGGED THINGS IN AS USUAL AND BEGAN THE CASE. ALL APPEARED NORMAL UNTIL THE PHYSICIAN WAS IN THE PATIENT AND THE ELECTROSURGICAL GENERATOR WOULD NOT FIRE. IT DID NOT RESPOND TO PEDAL STEPS OR RESETS. IT DID NOT RESPOND TO NEW LOOPS. ALL CONNECTIONS WERE CHECKED AND RESET WITHOUT SUCCESS. THUS, THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819402 ↗
• InjuryFeb 11, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED DURING SEDATION OF A THERAPEUTIC CYSTOSCOPY THE GENERATOR HAD THE INCORRECT QUICK REFERENCE GUIDE. THIS CAUSED A SURGICAL PROLONGATION GREATER THAN 30 MINUTES AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356076 ↗
• InjuryFeb 11, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED DURING SEDATION OF A THERAPEUTIC CYSTOSCOPY THE GENERATOR HAD THE INCORRECT QUICK REFERENCE GUIDE. THIS CAUSED A SURGICAL PROLONGATION GREATER THAN 30 MINUTES AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356065 ↗
• InjuryNov 20, 2024Output Problem; Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732910 ↗
• InjuryNov 20, 2024Output Problem; Output Problem

  DURING SEDATION OF AN UNKNOWN THERAPEUTIC PROCEDURE THERE WAS A DELAY GREATER THAN 30 MINUTES DUE TO THE GENERATOR DISPLAYING AN E0728 INTERNAL HARDWARE FAILURE ERROR. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732901 ↗
• MalfunctionJun 7, 2024Defective Component; Defective Component

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE GENERATOR HAD A BAD FLEXRAY FIELD PROGRAMMABLE GATE ARRAY BOARD WHICH CAUSED THE ERROR 1010. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485182 ↗
• InjuryOct 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  AN OLYMPUS REPRESENTATIVE REPORTED, ON BEHALF OF THE CUSTOMER, THERE WAS AN ERROR CODE 1010 DISPLAYED AND THE DEVICE WOULD SHUT DOWN WHEN USING AN ELECTROSURGICAL GENERATOR "ESG-410". THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (TRANSURETHRAL RESECTION OF BLADDER TUMOR-TURBT) WHICH LED TO THE CASE BEING ABORTED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881621 ↗
• InjuryOct 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  AN OLYMPUS REPRESENTATIVE REPORTED, ON BEHALF OF THE CUSTOMER, THERE WAS AN ERROR CODE 1010 DISPLAYED AND THE DEVICE WOULD SHUT DOWN WHEN USING AN ELECTROSURGICAL GENERATOR "ESG-410". THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (TRANSURETHRAL RESECTION OF BLADDER TUMOR-TURBT) WHICH LED TO THE CASE BEING ABORTED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881541 ↗