EndoBeam™ Holmium Laser Fiber RU0550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741122262), received between Jun 26, 2018 and Jun 26, 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. 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.

• MalfunctionJun 26, 2018Break; Thermal Decomposition of Device; Kinked; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE FIBER (AT THE 5TH USAGE) BROKE IN THE MIDDLE; THE PORTION EXTERNAL TO THE FLEXIBLE URETERORENOSCOPE. DURING THE PUSHING PROCEDURE, THE FIBER KINKED AND BROKE, WHICH CAUSED BURNING OF THE GLOVE AND OF ONE FINGER OF THE OPERATOR. THE PATIENT WAS NOT INJURED. THE OPERATOR OF THE DEVICE DID NOT SEEK MEDICAL INTERVENTION.

  Patient problems: Burn(s); Radiation Burn

  MAUDE report 7639702 ↗