DEKA SMARTXIDE TOUCH M110C1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08057017760153), received between Apr 12, 2018 and Feb 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Human Factors Issue” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JANUARY THE 25TH, 2021, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US AGENT EMERGO, THAT RECEIVED A COMMUNICATION FROM THE FDA, CONCERNING AN ADVERSE EVENT HAPPENED TO A PATIENT RECORDED ON THE MEDWATCH SYSTEM. THE PATIENT REPORTED TO THE FDA (MEDWATCH REPORT #MW5098664), ON (B)(6) 2020 AN ADVERSE EVENT HAPPENED TO HER, FOLLOWING THE FIRST OF THREE MONALISA TOUCH TREATMENT PERFORMED IN DATE (B)(6) 2020. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT WAS NOT IDENTIFIED BY THE PATIENT IN THE MEDWATCH REPORT. ANYWAY THE PATIENT SUPPLIED HER GENERALITIES AND CONTACT INFORMATION ON THE MW5098664 REPORT. THE PATIENT REPORTED TO HAVE UNDERWENT THE FIRST TREATMENT IN ORDER TO ALLEVIATE SOME MENOPAUSAL SYMPTOMS THAT SHE HAVE SINCE 2017, YEAR IN WHICH SHE RECEIVED AN HYSTERECTOMY. HER SYMPTOMS WERE VAGINAL DRYNESS AND PAINFUL INTERCOURSE. THE PATIENT ALSO SPECIFIED THAT SHE IS A BREAST CANCER SURVIVOR AND CAN'T USE HORMONAL TREATMENT. THE PHYSICIAN WHO ADVISED THE PATIENT PRESENTED THE MONALISA TOUCH AS HER "ONLY CHANCE" TO ALLEVIATE HER SYMPTOMS. THE PHYSICIAN STATED TO THE PATIENT TO HAVE TREATED WITH SUCCESS SEVERAL WOMEN IN THE SAME CONDITIONS AS

  Patient problems: Pain

  MAUDE report 11364152 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2018, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY ONE PATIENT TO THE FDA, THROUGH THE MEDWATCH SYSTEM. THE PATIENT, MRS (B)(6), REPORTED TO THE FDA (MEDWATCH REPORT #MW5079224), (B)(6) 2018, AN ADVERSE EVENT HAPPENED TO HER, FOLLOWING 3 MONALISA TOUCH TREATMENT PERFORMED BY HER UROLOGIST IN DATES (B)(6) 2017, (B)(6) 2018 AND (B)(6) 2018. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT IS THE DEKA SMARTXIDE TOUCH (REF: M110C1 - S/N: (B)(4)) MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, CLEARED BY THE FDA UNDER 510(K) K133859. THE PATIENT REPORTED TO HAVE BEEN TREATED WITH MONALISA TOUCH FOR 3 TIMES FOR VAGINAL DRYNESS AND PAIN DURING INTERCOURSE. FOLLOWING THE TREATMENT HER URINARY FREQUENCY GOT WORSE AND SHE HAD CHRONICAL VAGINAL PAIN. SHE AFFIRMS TO HAVE BEEN DIAGNOSED WITH YEAST INFECTION, LICHEN SCLEROSUS, DYSPAREUNIA, ATROPHIC VAGINITIS. SHE IS NOW TREATED WITH FLONASE, BUPROPION, WOMEN'S DAILY VITAMIN, OMEGA 3 VITAMIN, MELATONIN. MOREOVER THE PATIENT AFFIRMS TO GET SCHEDULED FOR PELVIC FLOOR THERAPY. THE US IMPORTER (B)(4) HAS BEEN INFORMED OF THE EVENT AS SOON AS POSSIBLE IN DATE (B)(4) 2018 IN ORDER TO CARRY A THROUGHLY INV

  Patient problems: Inflammation; Pain; Unspecified Infection; Urinary Frequency / Polyuria

  MAUDE report 7901834 ↗
• InjuryApr 12, 2018Human Factors Issue; Adverse Event Without Identified Device or Use Problem; Human Factors Issue; Adverse Event Without Identified Device or Use Problem

  (B)(4) (US IMPORTER) (B)(4) REPORTS OF AN ADVERSE EVENT HAPPENED AT (B)(6), US INVOLVING A SMARTXIDE TOUCH LASER MEDICAL DEVICE (REF: M110C1 - S/N: (B)(4)) MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4). BASED ON THE INVESTIGATION PERFORMED BY (B)(4) PERSONNEL THEY FOUND THAT THE SCANNER HAS DETACHED FROM THE DEVICE'S ARTICULATED ARM DURING A TREATMENT AND FIRED UPON THE PHYSICIAN'S NECK. (B)(4) REPORTS THAT,DESPITE NUMEROUS ATTEMPT TO CONTACT THE CUSTOMER, IT WAS UNRESPONSIVE AND NO ADDITIONAL INFORMATION RELATED TO THE INJURY OCCURED TO THE PHYSICIAN, PARAMETER USED AND PROCEDURE WAS RECEIVED. THIS INCIDENT WAS CLASSIFIED AS A REPORTABLE EVENT BY THE US IMPORTER DUE TO THE INJURY REPORTED BY THE OPERATOR (ACCORDING TO FDA 21 CFR PART 803 - ASSUMED AS A WORST CASE SCENARIO, ON THE SIDE OF CAUTION) AND BECAUSE THE DETACHMENT OF THE SCANNER CAUSED AN ACCIDENTAL RADIATION OCCURENCE (ACCORDING TO FDA 21 CFR PART 1000-1040). THIS ARO IS REPORTED TO THE FDA UNDER THE MDR PROCEDURE ACCORDING TO FDA 21 CFR PART 1003.10.1.C). THE US IMPORTER, (B)(4) LOCATED IN (B)(4), SUBMITTED AN MDR INITIAL REPORT TO FDA FOR THIS EVENT (#1222993-2018-00006) ON MARCH 27TH, 2018 . (B)(4). ALSO REPRES

  Patient problems: Burn(s)

  MAUDE report 7424573 ↗