Optilite G48625Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002486256), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 2, 2018Crack; Material Separation

  THE COMPLAINANT REPORTED THAT THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER SEPARATED DURING A URETERAL LASER LITHOTRIPSY, SO ANOTHER DEVICE WAS USED. IT WAS FURTHER NOTED THAT THE FIBER WAS CRACKED ALONG THE LENGTH. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742305 ↗