DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4 M104K1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08057017760108), received between Nov 16, 2016 and Nov 16, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2016Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4) SALES AGENT FOR (B)(6) MR. (B)(6) NOTICED US ABOUT AN ADVERSE EVENT HE RECENTLY BECAME AWARE OF. INVOLVED DEVICE IS DEKA SYNCHRO REPLAY EXCELLIUM 3.4 MODEL NUMBER M104H1, S/N (B)(4), MANUFACTURED BY (B)(4). THE ACTUAL DATE OF THE EVENT IS UNKNOWN (BEST ESTIMATE DATE OF THE EVENT (B)(6) 2016) AND (B)(4) BECAME AWARE OF THE EVENT ON (B)(6) 2016. EVENT TOOK PLACE IN THE (B)(6). OUR SERVICE TECHNICIAN VISITED THE CUSTOMER AND INFORMED US THAT ONE DEKA SYNCHRO REPLAY EXCELLIUM 3.4 WAS INVOLVED IN A LASER TREATMENT FOR FACE BENIGN PIGMENTATED LESIONS (DARK SPOT ON CHEEK) ON PATIENT WHO DEVELOPED A BURN ON CHEEK. WE, THE MANUFACTURER OF THE DEVICE DEKA SYNCHRO REPLAY EXCELLIUM 3.4 MARKETED IN THE US TERRITORY, ACCORDING TO 21 CFR 803.50 SUBMITTED TO FDA AN OWN INITIAL 30 DAYS MDR REPORT. THIS EVENT IS REPORTED TO FDA IN THE SIDE ORF CAUTION DUE TO THE FACT THAT WE DID NOT HAVE ANY INFORMATION CONCERNING THE STATE OF HEALING OF THE PATIENT AT THE TIME AND THAN WE CONSIDER THE BURN AS A POTENTIAL EVOLVING TO A PERMANENT DAMAGE.

  Patient problems: Burn(s)

  MAUDE report 6105783 ↗