The neoprobe npb09s is a reusable gamma detection probe that is cleaned and disinfected and/or sterilized between uses.Based on the review of the dhr, the device was manufactured in oct.2013, and released for commercial use having met all acceptance tests and calibration criteria.The device has not been received at the site of manufacture, nortech.A supplemental report will be submitted once the evaluation is complete.While there was no adverse effect during this event, there is a potential for serious injury if malfunction were to reoccur.This potential serious injury would be from an infection due to cross contamination and/or the tip of the neoprobe falling off during the procedure and being left behind in the body.Possible causes of this defect would be deficient expoxy or a loose probe, pursuant to 21 cfr 803, we are deeming this a reportable event and thus submitting this medwatch report.
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