EVOLVE SYSTEM WITH TRANSFORM APPLICATOR

Description of Event or Problem

SECOND DEGREE BURNS ON ABDOMEN FOLLOWING TREATMENT WITH THE TRANSFORM APPLICATOR.

Additional Manufacturer Narrative

A DOCTOR REPORTED OF A PATIENT SUSTAINING SMALL (LESS THAN 1CM) THIRD DEGREE BURN ON HIS ABDOMEN FOLLOWING TREATMENT WITH TRANSFORM APPLICATOR THAT TOOK PLACE 2.5 YEARS AGO. UP TO DATE, NO PHOTOS NOR CLINICAL FORM HAVE BEEN PROVIDED TO INMODE TO ENABLE CLINICAL ASSESSMENT OF THIS ALLEGED ADVERSE EVENT. TECHNICAL ISSUE IDENTIFIED DURING SERVICE INSPECTION WAS EXCLUDED AS POSSIBLE CAUSE OF A BURN. DUE TO LACK OF INFORMATION AND COOPERATION FROM DOCTOR'S SIDE, WE CANNOT ESTABLISH THE ROOT CAUSE OF THIS ALLEGED EVENT. NEVERTHELESS, IT WAS DECIDED TO REPORT THIS INCIDENT OUT OF "ABUNDANCE OF CAUTION". (B)(6) 2025: FU REPORT IS SUBMITTED WITH THE FOLLOWING CORRECTIONS/UPDATES: PATIENT'S RACE A6 CORRECTED. DATE OF EVENT B3 CORRECTED EVENT DESCRIPTION B5 CORRECTED PATIENT'S AGE ADDED. INMODE RECEIVED PHOTOS AND A CLINICAL FORM FROM THE DOCTOR. THIS COMPLAINT WAS IDENTIFIED TO BE A DUPLICATE OF ANOTHER COMPLAINT RECEIVED FROM THIS CLINIC BACK IN 2023. FOLLOWING CLINICAL ASSESSMENT OF THE PHOTOS, THE BURNS WERE ASSESSED TO BE OF PARTIAL THICKNESS, AND THEREFORE IT WAS DECIDED TO DOWNGRADE THIS REPORT TO NON-SERIOUS. SUCH SMALL AND SUPERFICIAL LESIONS ARE EXPECTED TO HEAL WITH ONLY A POSSIBILITY OF SOME TRIVIAL COSMETIC DAMAGE. AS TECHNICAL ISSUE IDENTIFIED DURING SERVICE INSPECTION WAS EXCLUDED AS A POSSIBLE CAUSE OF THE BURNS, INVESTIGATION ATTRIBUTED THE ROOT-CAUSE TO FOCAL LACK OF COUPLING GEL OR INCOMPLETE CONTACT OF THE APPLICATOR WITH THE SKIN, COMBINED WITH LONG TIME OF RF APPLICATION.

Description of Event or Problem

ALLEGED THIRD DEGREE BURN AND SCARRING ON ABDOMEN FOLLOWING TREATMENT WITH THE TRANSFORM APPLICATOR

Additional Manufacturer Narrative

A DOCTOR REPORTED OF A PATIENT SUSTAINING SMALL (LESS THAN 1CM) THIRD DEGREE BURN ON HIS ABDOMEN FOLLOWING TREATMENT WITH TRANSFORM APPLICATOR THAT TOOK PLACE 2.5 YEARS AGO. UP TO DATE, NO PHOTOS NOR CLINICAL FORM HAVE BEEN PROVIDED TO INMODE TO ENABLE CLINICAL ASSESSMENT OF THIS ALLEGED ADVERSE EVENT. TECHNICAL ISSUE IDENTIFIED DURING SERVICE INSPECTION WAS EXCLUDED AS POSSIBLE CAUSE OF A BURN. DUE TO LACK OF INFORMATION AND COOPERATION FROM DOCTOR'S SIDE, WE CANNOT ESTABLISH THE ROOT CAUSE OF THIS ALLEGED EVENT. NEVERTHELESS, IT WAS DECIDED TO REPORT THIS INCIDENT OUT OF "ABUNDANCE OF CAUTION".