Optilite G48522Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002485225), received between Mar 17, 2016 and Mar 17, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionMar 17, 2016Material Separation; Material Separation

  DURING A URETEROSCOPY LAZER LITHOTRIPSY PROCEDURE, THE TIP OF THE OPTILITE MULTI-USE HOLMIUM LASER FIBER CAME OFF IN THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP WITH NO HARM TO THE PATIENT. THE TIP OF THE DEVICE WAS SUCCESSFULLY REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5508440 ↗