EndoBeam™ Holmium Laser Fiber SU1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741122231), received between Jul 19, 2017 and Aug 30, 2018 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE LASER FIBER TIP WAS BENT. ALLEGEDLY ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7835711 ↗
• MalfunctionJul 19, 2017Component Missing

  IT WAS REPORTED THAT THE DISTAL TIP OF THE FIBER (EXPOSED PORTION) WAS MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727230 ↗