Olympus WA47707SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14042761085547), received between Nov 7, 2025 and May 12, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Fracture1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Break
IT WAS REPORTED THE RESECTION ELECTRODE BIPOLAR LOOP BROKE. THE ISSUE WAS FOUND DURING A BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE, THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153172 ↗MalfunctionApr 2, 2026Break
IT WAS REPORTED THE HF-RESECTION ELECTRODE PLASMA LOOP BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC RTU BIPOLAR PROSTATE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767260 ↗MalfunctionDec 10, 2025Break; Melted; Break; Melted
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770101 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THE RESECTION ELECTRODE PLASMA LOOP BROKE AND STOPPED WORKING DURING AN UNKNOWN PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700580 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THE RESECTION ELECTRODE PLASMA LOOP WAS BROKEN DURING AN UNKNOWN PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700540 ↗MalfunctionNov 19, 2025Break; Break
IT WAS REPORTED THE RESECTION ELECTRODE LOOP BROKE AT THE BEGINNING OF A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23599531 ↗MalfunctionNov 7, 2025Fracture; Fracture
IT WAS REPORTED THE HF-RESECTION ELECTRODE "PLASMALOOP" HAD THE ELECTRODE LOOP SNAP WHILE RESECTING. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23500967 ↗
Other Electrode, Electrosurgical, Active, Urological devices
- M3 Gold M3-30AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- 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.