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Olympus Monopolar Hf Resection Electrodes
- Starting date:
- April 26, 2017
- Posting date:
- May 31, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63406
Reason
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.
Affected products
Olympus Monopolar Hf Resection Electrodes
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
A22201C
WA22037C
Companies
- Manufacturer
-
Olympus Winter & IBE GMBH
Kuehnstrasse 61
Hamburg
22045
GERMANY