Aura XP 0010-8118DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878953001678), received between Oct 12, 2018 and Jul 21, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE KTP LASER SCOPE WAS BROKEN. THE PATIENT WAS PRESENT AND UNKNOWN IF SEDATED. THE PROCEDURE WAS ABORTED DUE TO THE ISSUE WITH THE SCOPE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10305192 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING PREPARATION FOR A PROSTATE PROCEDURE THE CONSOLE DISPLAYED ERROR 40. THE CONSOLE WAS REBOOTED COMPLETELY AND ERROR 42 WAS DISPLAYED. THE ERROR COULD NOT BE RESOLVED AND THE PROCEDURE WAS ABORTED. NO PATIENT OUTCOME INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478121 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE AURA CONSOLE WAS STUCK IN THE WARMING UP STATE AND SHOWED ERROR 20. THE CASE COULD NOT BE COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT OUTCOME INFORMATION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8140218 ↗
• MalfunctionDec 3, 2018Smoking; Smoking

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE THE PATIENT WAS GOING THROUGH A BREATHING TREATMENT AND THE LASER WAS GOING THROUGH THE WARM UP SEQUENCE, THE NURSE NOTED THAT THE OPERATING ROOM WAS SMOKEY AND HAD A STINKY ODOR. THE LASER WAS TURNED OFF AND TAKEN OUTSIDE THE OPERATING ROOM. THE PROCEDURE WAS PERFORMED AND COMPLETED BY UNKNOWN ALTERNATIVE METHOD. THERE WAS NO PATIENT INJURY DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125138 ↗
• MalfunctionOct 12, 2018Smoking; Smoking

  IT WAS REPORTED THAT DURING A SCHEDULED PREVENTIVE MAINTENANCE THE CONSOLE STARTED SMOKING. THERE WAS NO PROCEDURE OR PATIENT INVOLVED. IT WAS NOTED THAT THE POWER SUPPLY NEEDS TO BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 7959641 ↗