Optilite G48626Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002486263), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 3, 2018Break; Crack

  IT WAS REPORTED THAT WHEN THE PHYSICIAN PLACED THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER IN THE SCOPE, THEY FOUND THAT IT WAS BROKEN. IT WAS LATER FOUND THAT CRACKS WERE VISIBLE ALONG THE LENGTH OF THE FIBER. THE PROCEDURE WAS COMPLETED WITH A NEW FIBER. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED, AND NO FRAGMENTS OF THE FIBER WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7748636 ↗