Olympus WA47540SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
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 · Recall details · FDA record ↗
Other Electrode, Electrosurgical devices
- Olympus WA47506SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical1 recall35 reports
- Olympus WA47566SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical1 recall0 reports
- Olympus WA47555SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical1 recall0 reports
- CONCEPT HEATWAVE CS-023Conmed Corporation · Electrode, electrosurgical2 reports
- CONCEPT HEATWAVE CS-024Conmed Corporation · Electrode, electrosurgical1 report
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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