Olympus A22205DRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14042761036716), received between Mar 8, 2023 and Oct 17, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 8, 2023Open, Classified
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
Z-2413-2023 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Break3
- Material Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE RUPTURED DURING A TRANSURETHRAL RESECTION OF A BLADDER TUMOR PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23328788 ↗MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE RUPTURED DURING A TRANSURETHRAL RESECTION OF A BLADDER TUMOR PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325679 ↗MalfunctionSep 5, 2025Break; Break
IT WAS REPORTED THAT THREE HIGH FREQUENCY RESECTION ELECTRODES BROKE. THE EVENTS OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTRATE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A FOURTH SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22985944 ↗MalfunctionMar 8, 2023Material Frayed; Material Frayed
AN OLYMPUS REPRESENTATIVE REPORTED, THAT DURING A THERAPEUTIC PROCEDURE FOR A TRANS-URETHRAL RESECTION OF PROSTATE, THE WIRE ON THE DISTAL END WAS FRAYED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16506138 ↗MalfunctionMar 8, 2023Material Frayed; Material Frayed
AN OLYMPUS REPRESENTATIVE REPORTED, THAT DURING A THERAPEUTIC PROCEDURE FOR A TRANS-URETHRAL RESECTION OF PROSTATE, THE WIRE ON THE DISTAL END WAS FRAYED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16505998 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.