Olympus WB990311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14042761083536), received between Dec 9, 2021 and Dec 9, 2021 — classified as 2 injuries.

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.

• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS AFTER A RADIOFREQUENCY ABLATION (RFA) OF THE SOFT PALATE USING A CELON PRO SLEEP PLUS HAND PIECE, NECROSIS WAS FOUND BILATERALLY ON THE SUPERIOR AND INFERIOR ASPECTS OF THE SOFT PALATE. THE PATIENT EXPERIENCED PAIN FROM THE NECROSIS. THERE IS NO OBVIOUS VELOPHARYNGEAL INSUFFICIENCY (VPI) OR NASAL REGURGITATION AS OF YET. THE NECROSIS WAS TREATED WITH ANTIBIOTICS AND PERIDEX (ANTISEPTIC ORAL RINSE). THE PATIENT'S CURRENT CONDITION IS DESCRIBED AS "IMPROVING".

  Patient problems: Burn(s); Necrosis

  MAUDE report 12972363 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS AFTER A RADIOFREQUENCY ABLATION (RFA) OF THE SOFT PALATE USING A CELON PRO SLEEP PLUS HAND PIECE, NECROSIS WAS FOUND BILATERALLY ON THE SUPERIOR AND INFERIOR ASPECTS OF THE SOFT PALATE. THE PATIENT EXPERIENCED PAIN FROM THE NECROSIS. THERE IS NO OBVIOUS VELOPHARYNGEAL INSUFFICIENCY (VPI) OR NASAL REGURGITATION AS OF YET. THE NECROSIS WAS TREATED WITH ANTIBIOTICS AND PERIDEX (ANTISEPTIC ORAL RINSE). THE PATIENT'S CURRENT CONDITION IS DESCRIBED AS "IMPROVING".

  Patient problems: Necrosis; Pain

  MAUDE report 12972319 ↗