Olympus WB991007Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042768910074), received between Aug 7, 2019 and Nov 18, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Fire” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE UNIT HAD NO OUTPUT AND IT WAS NOT FIRING. THE UNIT WAS SHOWING A SIGNAL THAT THE PROBE WAS NOT IN THE CORRECT PLACE EVEN WHEN IT WAS. IN ADDITION, THE PHYSICIAN REPORTED THAT THE UNIT IS SHOCKING PATIENTS IN ADDITION TO THE PROBES NOT WORKING WHEN PROPERLY PLACED IN THE TURBINATE ANATOMY. THE USER FACILITY FURTHER REPORTED THAT THERE WERE ACTUALLY TWO PATIENTS INVOLVED. BOTH OF THE PATIENTS HAD A NASAL SUBMUCOUS TURBINATE REDUCTION PROCEDURE. THERE WAS NO REPORTED PERMANENT DAMAGE WITH BOTH PATIENTS AND NO ADDITIONAL INTERVENTION PROVIDED TO THE PATIENTS. THIS REPORT IS 2 OF 2 REPORTS, AND IS RELATED TO (B)(4).

  Patient problems: Electric Shock

  MAUDE report 10864822 ↗
• InjuryNov 18, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE UNIT HAD NO OUTPUT AND IT WAS NOT FIRING. THE UNIT WAS SHOWING A SIGNAL THAT THE PROBE WAS NOT IN THE CORRECT PLACE EVEN WHEN IT WAS. IN ADDITION, THE PHYSICIAN REPORTED THAT THE UNIT IS SHOCKING PATIENTS IN ADDITION TO THE PROBES NOT WORKING WHEN PROPERLY PLACED IN THE TURBINATE ANATOMY. THE USER FACILITY FURTHER REPORTED THAT THERE WERE ACTUALLY TWO PATIENTS INVOLVED. BOTH OF THE PATIENTS HAD A NASAL SUBMUCOUS TURBINATE REDUCTION PROCEDURE. THERE WAS NO REPORTED PERMANENT DAMAGE WITH BOTH PATIENTS AND NO ADDITIONAL INTERVENTION PROVIDED TO THE PATIENTS. THIS REPORT IS 2 OF 2 REPORTS, AND IS RELATED TO (B)(4).

  Patient problems: Shock

  MAUDE report 10864721 ↗
• InjuryNov 17, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE UNIT HAD NO OUTPUT AND IT WAS NOT FIRING. THE UNIT WAS SHOWING A SIGNAL THAT THE PROBE WAS NOT IN THE CORRECT PLACE EVEN WHEN IT WAS. IN ADDITION, THE PHYSICIAN REPORTED THAT THE UNIT IS SHOCKING PATIENTS IN ADDITION TO THE PROBES NOT WORKING WHEN PROPERLY PLACED IN THE TURBINATE ANATOMY. THE USER FACILITY FURTHER REPORTED THAT THERE WERE ACTUALLY TWO PATIENTS INVOLVED. BOTH OF THE PATIENTS HAD A NASAL SUBMUCOUS TURBINATE REDUCTION PROCEDURE. THERE WAS NO REPORTED PERMANENT DAMAGE WITH BOTH PATIENTS AND NO ADDITIONAL INTERVENTION PROVIDED TO THE PATIENTS. THIS REPORT IS 1 OR 2 REPORTS AND THIS IS RELATED TO PATIENT IDENTIFIER NUMBER (B)(6).

  Patient problems: Electric Shock

  MAUDE report 10849687 ↗
• InjuryNov 16, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE UNIT HAD NO OUTPUT AND IT WAS NOT FIRING. THE UNIT WAS SHOWING A SIGNAL THAT THE PROBE WAS NOT IN THE CORRECT PLACE EVEN WHEN IT WAS. IN ADDITION, THE PHYSICIAN REPORTED THAT THE UNIT IS SHOCKING PATIENTS IN ADDITION TO THE PROBES NOT WORKING WHEN PROPERLY PLACED IN THE TURBINATE ANATOMY. THE USER FACILITY FURTHER REPORTED THAT THERE WERE ACTUALLY TWO PATIENTS INVOLVED. BOTH OF THE PATIENTS HAD A NASAL SUBMUCOUS TURBINATE REDUCTION PROCEDURE. THERE WAS NO REPORTED PERMANENT DAMAGE WITH BOTH PATIENTS AND NO ADDITIONAL INTERVENTION PROVIDED TO THE PATIENTS. THIS REPORT IS 1 OR 2 REPORTS AND THIS IS RELATED TO PATIENT IDENTIFIER NUMBER (B)(6).

  Patient problems: Shock

  MAUDE report 10849020 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT A FEW DAYS POST A THERAPEUTIC TURBINATE REDUCTION, THE PATIENT REPORTED EXPERIENCING A NUMB FEELING IN THEIR MOUTH. ACCORDING TO THE USER FACILITY, 30 DAYS AFTER THE PROCEDURE THE PATIENT CONTINUES TO EXPERIENCE THE NUMBNESS IN THE SAME AREA. IT IS UNKNOWN IF THE PATIENT WAS TREATED.

  Patient problems: Numbness

  MAUDE report 8872097 ↗