Olympus WB990210Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14042768902106), received between Oct 25, 2022 and Jan 6, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Connection Problem” (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.
Reports received per month
Most reported problems
Device problems
- Connection Problem2
- Defective Device2
- No Device Output2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING A RADIOFREQUENCY TURBINATE REDUCTION (RFTR) PROCEDURE, THE SUBJECT DEVICE WOULD NOT CONNECT WITH THE SYSTEM. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080055 ↗InjuryJan 6, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING A RADIOFREQUENCY TURBINATE REDUCTION (RFTR) PROCEDURE, THE SUBJECT DEVICE WOULD NOT CONNECT WITH THE SYSTEM. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080000 ↗InjuryOct 25, 2022No Device Output; No Device Output
THE CUSTOMER REPORTS DURING A TURBINOPLASTY PROCEDURE USING A CELONPROBREATH, TWO DEVICES FAILED UPON INITIAL CLINICAL USE (DURING THE SAME PROCEDURE). THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND NO TREATMENT/INTERVENTION WAS REQUIRED AS A RESULT OF CANCELLING THE PROCEDURE. THE PROCEDURE HAS SINCE BEEN COMPLETED. THE PATIENT HAS NOT HAD A POST-OP FOLLOW-UP APPOINTMENT AFTER THE REPEAT PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ONE DEVICE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE OTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15668913 ↗InjuryOct 25, 2022Defective Device
THE CUSTOMER REPORTS DURING A TURBINOPLASTY PROCEDURE USING A CELONPROBREATH, TWO DEVICES FAILED UPON INITIAL CLINICAL USE (DURING THE SAME PROCEDURE). THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND NO TREATMENT/INTERVENTION WAS REQUIRED AS A RESULT OF CANCELLING THE PROCEDURE. THE PROCEDURE HAS SINCE BEEN COMPLETED. THE PATIENT HAS NOT HAD A POST-OP FOLLOW-UP APPOINTMENT AFTER THE REPEAT PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ONE DEVICE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE OTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15668796 ↗InjuryOct 25, 2022Defective Device
THE CUSTOMER REPORTS DURING A TURBINOPLASTY PROCEDURE USING A CELONPROBREATH, TWO DEVICES FAILED UPON INITIAL CLINICAL USE (DURING THE SAME PROCEDURE). THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND NO TREATMENT/INTERVENTION WAS REQUIRED AS A RESULT OF CANCELLING THE PROCEDURE. THE PROCEDURE HAS SINCE BEEN COMPLETED. THE PATIENT HAS NOT HAD A POST-OP FOLLOW-UP APPOINTMENT AFTER THE REPEAT PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ONE DEVICE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE OTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15668639 ↗InjuryOct 25, 2022No Device Output; No Device Output
THE CUSTOMER REPORTS DURING A TURBINOPLASTY PROCEDURE USING A CELONPROBREATH, TWO DEVICES FAILED UPON INITIAL CLINICAL USE (DURING THE SAME PROCEDURE). THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND NO TREATMENT/INTERVENTION WAS REQUIRED AS A RESULT OF CANCELLING THE PROCEDURE. THE PROCEDURE HAS SINCE BEEN COMPLETED. THE PATIENT HAS NOT HAD A POST-OP FOLLOW-UP APPOINTMENT AFTER THE REPEAT PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ONE DEVICE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE OTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15668525 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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