GreenLight HPS EA 0010-2092Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953005522), received between Apr 5, 2019 and Jan 13, 2021 — classified as 2 malfunctions.

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. May 31, 2022Open, Classified

   Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

   Z-1392-2022 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

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.

• MalfunctionJan 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT IN A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE, THE BEAM WAS ALTERED AND NOT INCLINED FROM THE BEGINNING OF THE PROCEDURE. ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11164726 ↗
• MalfunctionApr 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PHOTO VAPORIZATION OF THE PROSTATE PROCEDURE THE QUARTZ LENS OF THE FIBER TIP FAILED DURING LASERING. THERE WERE NO DIFFICULTIES DURING THE USE OF THE FIBER AND NO COURTESY MESSAGED APPEARED ON THE CONSOLE. THE FIBER TIP REMAINED ATTACHED TO THE FIBER AND THERE WERE NO PHYSICAL BREAKS OF THE FIBER BODY OR TIP/CAP. IT IS NOTED THAT THE FIBER BEGAN TO END FIRE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489271 ↗