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Olympus Monopolar Hf Resection Electrodes — recall 44456

Health Canada — Medical Devices · Canada · 2017-05-31 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 44456
Date of alert: 2017-05-31
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: The manufacturer, Olympus Winter IBE (OWI), has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes. Investigations have confirmed that loop wires can break during the intended use of the electrodes. As a result, a fragment may fall inside the patient and will need to be retrieved. Under certain circumstances, the retrieval of this fragment could require additional surgical treatment.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/olympus-monopolar-hf-resection

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Olympus Monopolar Hf Resection Electrodes — recall 44456

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