Slimline SIS 365 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109140230), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 18, 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.

• MalfunctionNov 17, 2021Connection Problem; Connection Problem

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS LASER SYSTEM WAS BEING UTILIZED, THE LASER WAS NOT RECOGNIZING A LUMENIS SLIMLINE SIS 365 FIBER. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS CANCELED. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827837 ↗