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Medical device manufacturer, Terumo Cardiovascular System (Terumo CVS), has issued an Field Safety Notice concerning Sarns™ Sternal Saw I System.
Terumo CVS has received one report of minute metal shavings leaking from the Sarns™ Sternal Saw I System at the point where the saw blade is inserted into the saw hand piece. If metal shavings fall into the surgical site, the immediate and long range effect on the patient would be determined by the volume of metal and whether or not any other residue form inside the saw also leaked into the wound. The body would recognize the presence of the material as a foreign surface and would initiate an inflammatory response, which would range in severity from a mild localized response to a major systemic inflammatory response. Either of these could lead to an increase in morbidity to the cardiac surgery patient. No patient injury and no impact to the surgical procedure were reported with this incident.
Terumo CVS is removing all Sternal Saw I system from the field. According to the manufacturer, Hong Kong is NOT affected.
For details, please refer to the attached Field Safey Notice. If you are in possession of the affected products, please contact your supplier for necessary actions.
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