Olympus WA22657SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-resection electrode PlasmaButton button, 24 Fr., 12°-30°, PK TURis · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14042761085301), received between Jun 18, 2025 and Jun 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Nov 4, 2022Open, Classified
An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.
Z-0424-2023 · Root cause: Packaging process control · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287476 ↗MalfunctionJun 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE WHEN OPENED APPEARED TO HAVE PINHOLES IN THE TRIANGLE SHAPED AREA. THERE WERE NO REPORTS OF PATIENTS¿ HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284869 ↗
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 WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS 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.