Olympus A22206CRecalls & 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
- 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. How this data works · Data updated Oct 13, 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 · FDA record ↗
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- Dreamtome™ RX 44 M00584050Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall127 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Olympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)160 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.