COBLATOR II ENT EVAC 70 XTRA HP,W/INTEGRATED CABLE (BLUE/GREY)
Received Jul 2, 2026 · Event occurred Jun 9, 2026
Report 3032391-2026-00054 · MDR key 25696498
Device
Generic name
Eica5874-01 Coblator Ii,ent Evac 70 Xt
Manufacturer
Medline RenewalCatalog number
EICA58740RH
Lot number
565641
Product problems
- Failure to Prime
Patient
6 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED FROM THE CUSTOMER THAT THE TONSIL COBLATOR WAS HOOKED UP TO THE MACHINE. WHEN THE PROCEDURE WAS STARTING, THE SURGEON PRESSED THE FOOT PEDAL TO PRIME THE COBLATOR. FLUID WAS NOT RUNNING THROUGH THE TUBING, SO THEY REMOVED THE FAULTY COBLATOR FROM THE FIELD AND OPENED ANOTHER ONE TO FINISH THE CASE. THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
IT WAS REPORTED FROM THE CUSTOMER THAT THE TONSIL COBLATOR WAS HOOKED UP TO THE MACHINE. WHEN THE PROCEDURE WAS STARTING, THE SURGEON PRESSED THE FOOT PEDAL TO PRIME THE COBLATOR. FLUID WAS NOT RUNNING THROUGH THE TUBING, SO THEY REMOVED THE FAULTY COBLATOR FROM THE FIELD AND OPENED ANOTHER ONE TO FINISH THE CASE.