Olympus WA99516ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14042761085875), received between Mar 5, 2024 and Jan 16, 2025 — classified as 2 injuries, 2 malfunctions.

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

• InjuryJan 16, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, THE CAUTERY COULD NOT BE APPLIED WITH THE USE OF THE SUBJECT DEVICE. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. IT WAS THEN COMPLETED WITH THE USE OF A COMPETITOR DEVICE. THERE WERE NO REPORTS OF ADVERSE PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168254 ↗
• InjuryJan 16, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, THE CAUTERY COULD NOT BE APPLIED WITH THE USE OF THE SUBJECT DEVICE. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. IT WAS THEN COMPLETED WITH THE USE OF A COMPETITOR DEVICE. THERE WERE NO REPORTS OF ADVERSE PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168244 ↗
• MalfunctionMar 6, 2024Loss of or Failure to Bond; Physical Resistance/Sticking; Loss of or Failure to Bond; Physical Resistance/Sticking

  THE EVENT OCCURRED DURING A POLYPECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY. THE PATIENT WAS SEDATED WITH PROPOFOL, AND THERE WERE NO REPORTS OF PATIENT HARM. THE EXACT EVENT DATE WAS UNKNOWN BUT WAS APPROXIMATELY MID-FEBRUARY. RELATED TO PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852631 ↗
• MalfunctionMar 5, 2024Loss of or Failure to Bond; Physical Resistance/Sticking; Loss of or Failure to Bond; Physical Resistance/Sticking

  IT WAS REPORTED, THE NEUTRAL ELECTRODES DOES NOT STICK PROPERLY AND SOMETIMES HAVE TO BE RE-GLUED WITH ADDITIONAL PLASTERS. THE EVENT WAS FOUND DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839554 ↗