Olympus WA99510ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761085892), received between Jul 28, 2022 and Nov 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Device Output” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT DURING A POLYPECTOMY THE BLUE PEDAL AND GENERATOR DID NOT WORK. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND NO DELAY WAS REPORTED. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088295 ↗
• MalfunctionJul 28, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE ADULT PATIENT HAD A SUNBURN-LIKE BURN (REDNESS) TO AN UNSPECIFIED LOCATION OF THE LEG WHERE THE SUBJECT DEVICE WAS PLACED, IN A STRAIGHT LINE. THE OLYMPUS REPRESENTATIVE SURMISES THE SUBJECT DEVICE WAS NOT PLACED PROPERLY ON THE PATIENT AND CAUSED A HEAT BUILDUP. THE SUBJECT DEVICE WAS NOT BURNT. THE THERAPEUTIC ANAL FISTULA PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SUBJECT DEVICE WAS CONNECTED TO AN NON-OLYMPUS GENERATOR WITH THE SETTINGS AT 50/50 BLEND COAGULATION. THE SETTINGS WERE HIGH AND THE NON-OLYMPUS TEFLON PAD MELTED TOO. NO ALARMS WENT OFF DURING THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 15126995 ↗