Health Canada — Medical Devices · Canada · 2014-04-30 · Type III
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Reported risk: Potential hazard can occur with the MI1000 pin drill guide after repeated use and if wear is undetected. Med-El has determined that the MI1000 pin drills must no longer be used during cochlear implant surgery in the ENT clinic to prevent any harm arising from undetected wear. These drills do not fit standard noth american drill tools. However, should use of these drills be possible, a risk may exist.
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