MEGADYNE

Description of Event or Problem

ON APRIL 21ST, 2026, WE HAVE BEEN INFORMED OF AN ADVERSE EVENT INVOLVING TWO DISPERSIVE ELECTRODES. AN UNKNOWN PROCEDURE WAS PERFORMED UW HEALTH IN MADISON (USA). MEGADYNE DISPERSIVE ELECTRODE CATALOGUE NUMBER: 0855C (OUR MODEL: RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT: "IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THERE ARE TWO PATIENT INJURIES OCCURRING ON CONSECUTIVE DAYS. PADS ARE BURNING PATIENTS. UNINTENDED THERMAL INJURY LESS THAN 2ND DEGREE." IT WAS ALSO STATED IN THE INITIAL REPORT THAT THE INVOLVED "DEVICES ARE AVAILABLE FOR RETURN." NO INFORMATION ABOUT THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENTS, HOW THE SKIN WAS PREPARED, HOW THE INJURIES WERE TREATED AFTERWARDS AND A FILLED IN QUESTIONNAIRE HAVE BEEN DISCLOSED TO US SO FAR.

Additional Manufacturer Narrative

RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES OF THE CONCERNED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION, QUESTIONNAIRES TO BE COMPLETED AND THE CONCERNED CUSTOMER SAMPLES FOR TESTING. WE WILL PROVIDE A FOLLOW UP REPORT ONCE ANY FURTHER WILL BECOME AVAILABLE.