DERMATOME AN HANDPIECE

Additional Manufacturer Narrative

THIS INCIDENT IS BEING RECORDED UNDER (B)(4). THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE SURGERY THE HOSE IS LEAKING AIR. NO PATIENT HARM OR SURGICAL DELAY. DILIGENCE IS COMPLETE.