VersaPulse PowerSuite VersaPulse PowerSuite 60WRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07290109146218), received between Sep 1, 2022 and Jul 21, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Communication or Transmission Problem

  It was reported that during preparation prior to a procedure, when booting up the console to test fire, an error message appeared stating " "Maximum available Ho:Yag pulse rate reduced to 10Hz" and "Maximum available Ho:Yag power reduced to 20W". The technician restarted the console but error All lasers are malfunctioning, please call Coherent Service" appeared. There were no patient complications, the case had to be cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25897145 ↗
• MalfunctionApr 30, 2026Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE WAS NOT PROVIDING FULL POWER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048024 ↗
• MalfunctionSep 11, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE WAS DELIVERING REDUCED POWER AT LEVEL 30. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028191 ↗
• MalfunctionMar 26, 2025Failure to Power Up; Use of Device Problem; Failure to Power Up; Use of Device Problem

  IT WAS REPORTED THAT THE CONSOLE WILL NOT TURN ON AND THE EMERGENCY STOP BUTTON IS NOT OPERATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699403 ↗
• MalfunctionJan 2, 2024Smoking; Appropriate Device Problem Term/Code Not Available; Smoking; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A STROKE SMOKE SMELL WAS REPORTED WHEN SMOKE BECAME VISIBLE IN THE ROOM AND OUT TO THE HALLWAY DURING A CYSTOSCOPY CASE IN THE OPERATING ROOM. THIS IS INDICATIVE OF AN ELECTRICAL FAILURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432321 ↗
• MalfunctionOct 31, 2023Fluid/Blood Leak; Unintended Application Program Shut Down; Fluid/Blood Leak; Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING THE PROCEDURE THE CONSOLE WAS LEAKING WATER AND THE LASER AUTOMATICALLY SHUT DOWN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS STABLE UNDER GENERAL ANESTHESIA. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039162 ↗
• MalfunctionJun 15, 2023Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE CONSOLE DISPLAYED A LOW POWER MESSAGE ERROR AND DURING AN INSPECTION, IT WAS FOUND THAT THE HR AND OC MIRRORS ARE DAMAGED. THEN, THE MIRRORS WERE REPLACED, AND THE SYSTEM WORKED NORMALLY. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR A RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS NOT UNDER SEDATION WHEN THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139503 ↗
• MalfunctionJan 10, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED SEVERAL ERROR MESSAGES. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132799 ↗
• MalfunctionOct 4, 2022Defective Device; Connection Problem; Defective Device; Connection Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING AN URETEROSCOPY PROCEDURE TO REMOVE A KIDNEY STONE UTILIZING A HOLMIUM LASER CONSOLE. AN ERROR MESSAGE APPEARED ON THE LASER CONSOLE SCREEN INDICATING THERE WAS A FOOTSWITCH CONNECTION PROBLEM. THE SURGICAL TECHNICIAN AND NURSE RESTARTED THE LASER CONSOLE. IN ADDITION, THE FOOTSWITCH CORD WAS DISCONNECTED FROM AND RECONNECTED TO THE LASER CONSOLE, BUT THE ERROR MESSAGED PERSISTED. THE PHYSICIAN WAS UNABLE TO ACTIVATE THE LASER. THE FOOTSWITCH CORD THEN FELL OFF FROM THE LASER CONSOLE CONNECTING RECEPTACLE AND BREAKING INTO 3 PIECES. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE AND PLACED A URETERAL STENT TO ALLOW THE KIDNEY TO DRAIN. THE PHYSICIAN INFORMED THE PATIENT THAT SHE WOULD NEED TO RETURN FOR A SECOND PROCEDURE TO REMOVE THE STONE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537902 ↗
• MalfunctionSep 1, 2022Smoking; Adverse Event Without Identified Device or Use Problem; Smoking; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT SMOKE WAS COMING FROM THE FIBER PORT. NO ERRORS WERE RECEIVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338328 ↗