The neoprobe npb09s is a reusable gamma detection probe that is cleaned and disinfected and/or sterilized between uses.Based on review of the dhr, the device was manufactured in (b)(6) 2013 and released for commercial use having met all acceptance tests and calibration criteria.The device was received at the site of manufacture, (b)(4), on (b)(6) 2017.The device is currently in the evaluation process.A supplemental report will be submitted once the evaluation is complete.Further follow-up with customer indicated that the device was not in use in a procedure when the probe tip fell off.They were unable to confirm if the device had been dropped or knocked against another object but, did state that the probe was identified to have been damaged in sterile storage.While there was no adverse effect during this event, there is a potential for serious injury if the malfunction were to recur.This potential serious injury would be from an infection due to cross contamination and/or the tip of the neoprobe probe falling off during the procedure and being left behind in the body.Possible causes of this defect would be deficient epoxy or a loose probe tip.Both of these potential serious injuries could require a subsequent surgical procedure.Pursuant to 21 cfr 803, we are deeming this a reportable event and thus submitting this medwatch report.
|