Moxy 0010-2400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,572 adverse event reports that list this exact device (DI 00878953005515), received between Aug 22, 2017 and Sep 29, 2026 — classified as 65 injuries, 4,507 malfunctions.

The most frequently reported specific device problem is “Break” (1,589 reports).

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 25 most recent of 4,572 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Gas Output Problem; Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938826 ↗
• MalfunctionSep 29, 2026Separation Problem

  It was reported that during preparation/prior to procedure, with the fiber already connected, the connector head that connects the fiber to the laser equipment was broken. The procedure continued and completed with another Moxy fiber without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927810 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918056 ↗
• MalfunctionSep 28, 2026Break

  It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, three laser fibers were opened consecutively. The fibers lasted 90,000, 95,000, and 120,000 Joules respectively, before the piece of glass on the inside of the fiber broke. The procedure was completed with a fourth fiber without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917798 ↗
• MalfunctionSep 28, 2026Break

  It was reported that during a photo selective vaporization of the prostate procedure for benign prostatic hyperplasia, three laser fibers were opened consecutively. The fibers lasted 90,000, 95,000, and 120,000 Joules respectively, before the piece of glass on the inside of the fiber broke. The procedure was completed with a fourth fiber without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917786 ↗
• MalfunctionSep 28, 2026Firing Problem

  It was reported that during a Photoselective Vaporization of the Prostate procedure, the fiber began forward firing. The fiber was then replaced and the procedure was succesfully completed without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915506 ↗
• MalfunctionSep 22, 2026Break

  It was reported that during a photoselective vaporization of the prostate to treat benign prostatic hyperplasia, the fiber broke. No fiber fragments fell inside the patient's body, and there were no injuries to the operator of the fiber. The procedure was completed with a fiber replacement. The patient's condition following procedure was stable; there were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855110 ↗
• MalfunctionSep 17, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797160 ↗
• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797130 ↗
• MalfunctionSep 16, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795988 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793433 ↗
• MalfunctionSep 15, 2026Break

  It was reported that during a procedure, they were treating an immunosuppressed patient with KPC (multidrug-resistant bacteria) with contact prevention when it was noticed that the fiber optic cable showed detachment from the tip of the laser beam providing ineffective at the 70-degree beam. The procedure was completed with another device without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770970 ↗
• MalfunctionSep 14, 2026Nonstandard Device; Communication or Transmission Problem

  It was reported that during a Greenlight prostate vaporization procedure, the fiber started showing overheating error code. No specific error was reported. The procedure was completed with another fiber without patient injuries. Product investigation of the returned device identified a cap/tip fracture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751552 ↗
• MalfunctionSep 8, 2026Firing Problem

  It was reported that the fiber started forward firing after 29 min 54 sec of use. The procedure was completed with another device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672779 ↗
• MalfunctionSep 4, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600553 ↗
• MalfunctionSep 4, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600548 ↗
• MalfunctionAug 31, 2026Break; Firing Problem

  It was reported that during a photoselective vaporization of the prostate procedure to treat benign prostatic hyperplasia, the fiber glass cap tip broke and the fiber forward fired while treating the median lobe in the prostate. No fiber fragments fell inside the patient's body. The procedure was completed with a fiber replacement. The patient's outcome was stable. There were no patient complications nor injuries to the operator of the fiber.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515526 ↗
• MalfunctionAug 29, 2026Nonstandard Device; Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509871 ↗
• MalfunctionJul 28, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50049138 ↗
• MalfunctionJul 27, 2026Break

  It was reported that during procedure, the fiber tip was damaged as the metal cap detached. It became dislodged inside the body. The dislodged metal cap was removed from the body using forceps. The case was completed with another of same device without patient complications. The physician and the medical engineer reported that there was no movement that could have caused the tip to come off during the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000234 ↗
• MalfunctionJul 21, 2026Nonstandard Device; Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25899116 ↗
• MalfunctionJul 21, 2026Nonstandard Device; Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25896452 ↗
• MalfunctionJul 2, 2026Firing Problem

  IT WAS REPORTED THAT DURING GREENLIGHT VAPORIZATION PROCEDURE TO TREAT BPH (BENIGN PROSTATIC HYPERPLASIA), FORWARD FIRING OCCURRED. IT WAS INDICATED THAT THE GLAND VOLUME WAS 150 GRAMS. JOULES USED WAS 77000 J. THE LASER TIME EXPENDED WAS SEVENTEEN MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699815 ↗
• MalfunctionJun 25, 2026Nonstandard Device; Power Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE FIBER SOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THE FIBER RETURNED AND IT WAS ANALYZED IDENTIFYING THE GLASS TIP WAS DETACHED FROM THE DISTAL END OF THE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622775 ↗
• MalfunctionJun 18, 2026Break

  IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THERE WAS A REFLECTING MIRROR RUPTURE, AFTER THE FIBER WAS USED FOR 00:00:37 MINUTES WITH 8355 JOULES. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. THE GLAND VOLUME OF THE PATIENT WAS 100ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553604 ↗