Olympus WA22721SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaBand band, medium, 24 Fr., 12°/16°, ESG TURis · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761085370), received between Jun 6, 2024 and May 22, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Explosion1
- Output Problem1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Thermal Decomposition of Device; Explosion; Thermal Decomposition of Device; Explosion
IT WAS REPORTED THAT THE RESECTION ELECTRODE BROKE, CAUSING AN EXPLOSION AND BURNING THE OPTICS. THIS ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THERE WAS NO DELAY. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22070072 ↗MalfunctionJul 26, 2024Break; Break
IT WAS REPORTED THAT THE ELECTRODE LOOP HANDPIECE BROKE OFF AT THE DISTAL END. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839606 ↗InjuryJun 6, 2024Output Problem; Output Problem
IT WAS REPORTED, THAT THE ELECTROSURGICAL GENERATOR HAD INSUFFICIENT CONDUCTIVITY ERROR CODE: E006. THE ISSUE OCCURRED DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. IT WAS LATER REPORTED THE PROCEDURE WAS APPROXIMATELY TWO- THREE HOURS AND THE USUAL PROCEDURE TIME IS 45 MINUTES. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19474048 ↗
Other Electrode, Electrosurgical, Active, Urological devices
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- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.