ZMR AIR DERMATOME HANDPIECE

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, ON (B)(6) 2026, THE UNIT MADE A RATTLING NOISE DURING OPERATION AND IT WAS NOT TAKING THE SKIN PROPERLY. IT IS UNKNOWN IF THERE WAS A PATIENT IMPACT OR IF A DELAY OCCURRED. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4) G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.