CHATTANOOGA
Received Aug 14, 2025 · Event occurred Jul 17, 2025
Report 9616086-2025-00057 · MDR key 22812228
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT SUSTAINED DERMAL BURNS DURING COMBO MODALITY, NO ERROR MESSAGE RECEIVED ON THE DEVICE.
Additional Manufacturer Narrative
IT WAS REPORTED THAT PATIENT SUSTAINED DERMAL BURNS DURING COMBO MODALITY, NO ERROR MESSAGE RECEIVED ON THE DEVICE. THE PATIENTS BURN WAS DRESSED AND WAND WAS CLEANED AT THE TIME THE INJURY OCCURRED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.
Additional Manufacturer Narrative
SEE D9, H3, H6, AND H11. THE DEVICE HAS BEEN EVALUATED BY A TECHNICIAN, THE DEVICE WAS TESTED SEVERAL TIMES WITH ENOVIS LEAD WIRES. THE DEVISE WAS CALIBRATED AND TESTED THE APPLICATOR SEVERAL TIMES. THERE WERE NO ISSUES DISCOVERED DURING THE TESTING PROCESS. THE CUSTOMER DID NOT SEND IN THEIR ELECTRODES. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF MORE INFORMATION BECOMES AVAILABLE.