CyberWand USL Ultrasonic Lithotripsy System CW-USLSARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H891CWUSLSA4), received between Mar 4, 2021 and May 24, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Break; Protective Measures Problem; Device Handling Problem; Break; Protective Measures Problem; Device Handling Problem

  IT WAS REPORTED THAT THE CYBERWAND SYSTEM HAD A DAMAGED FOOT SWITCH AND THE FAULT LIGHT TURNED ON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396116 ↗
• MalfunctionJun 28, 2022Connection Problem; Connection Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE FAULT LIGHT WAS ON FOR THE CYBER-WAND AND THE CONNECTOR WAS NOTED DAMAGED. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848456 ↗
• MalfunctionSep 10, 2021Output Problem; Output Problem

  AS REPORTED, WHEN THE CUSTOMER ATTEMPTED TO ACTIVATE THE HANDPIECE IN THE CYBERWAND SYSTEM, A FAULT ERROR WOULD OCCUR AFTER TUNING THE HANDPIECE. CUSTOMER SWAPPED OUT THE HANDPIECE BUT THE SAME FAULT ERROR OCCURRED. THERE IS NO PATIENT INVOLVEMENT REPORTED ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457337 ↗
• MalfunctionMar 4, 2021Failure to Power Up; Failure to Power Up

  AS REPORTED, THE CYBERWAND SYSTEM GENERATOR WOULD NOT POWER ON. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413766 ↗