VersaPulse PowerSuite VersaPulse PowerSuite 80/100W (REF 0638-800-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290109146164), received between Nov 8, 2022 and Nov 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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.

• MalfunctionNov 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A CYSTOSCOPY LITHOTRIPSY PROCEDURE, THE CONSOLE DISPLAYED A MESSAGE INDICATING "ALL LASERS ARE MALFUNCTIONING, PLEASE CALL FOR SERVICE." THE CONSOLE STOPPED WORKING, AND THE PROCEDURE WAS CANCELLED WITH THE PATIENT ALREADY UNDER SEDATION. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT AND SHOWED NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633113 ↗
• MalfunctionApr 16, 2024Device Displays Incorrect Message; Output below Specifications; Unintended Application Program Shut Down; Device Displays Incorrect Message; Output below Specifications; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN UNEXPECTEDLY SHUT OFF, THE LASER CONSOLE WAS REBOOTED. IT WAS TRIED TO GO ABOVE 0.6 JOULE AND IT SHUTS OFF AGAIN. AN ENERGY HIGH FAULT MESSAGE APPEARED; AND IT HAPPENED A COUPLE TIMES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, USED AT A LOWER SETTING, WHICH TOOK LONGER TO COMPLETE BUT THEY WERE ABLE TO SAFELY COMPLETE. THE PATIENT WAS UNDER GENERAL ANESTHESIA IN STABLE CONDITION, THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19118930 ↗
• MalfunctionSep 28, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED GENERAL ANESTHESIA IN PREPARATION FOR A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, IT WAS FOUND THAT THE TOUCH SCREEN ON THE CONSOLE WAS NOT WORKING PROPERLY. PUSHING THE BUTTONS ON THE SCREEN WAS NOT DOING ANYTHING. THE CONSOLE WAS RESTARTED BUT THE ISSUE DID NOT RESOLVE. THE CONSOLE WAS THEN SHUT DOWN, UNPLUGGED, PLUGGED BACK IN, AND THEN STARTED AGAIN. THE CONSOLE PASSED SELF-TEST, BUT THE TOUCH SCREEN STILL WAS NOT WORKING. IT WAS NOTED THAT NO ERROR CODES WERE RECEIVED. THE PROCEDURE WAS THEN CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17837884 ↗
• MalfunctionAug 30, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Unintended Application Program Shut Down; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER THE PATIENT WAS SEDATED, THE CONSOLE WAS SHUTTING DOWN ON ITS OWN. AN ERROR MESSAGE WAS PROMPTED STATING "ALL LASERS MALFUNCTIONING, CONTACT SERVICE." THE CONSOLE WAS RESTARTED AND ERROR 801 WAS PROMPTED. A FIBER WAS CONNECTED TO THE CONSOLE, HOWEVER, THE SAME ERROR OCCURRED. THE ERROR MESSAGES COULDN'T BE CLEARED TO CONTINUE USE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR PROCEDURE ABORTED AFTER PATIENT SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653458 ↗
• MalfunctionNov 8, 2022Device Displays Incorrect Message; Firing Problem; Device Displays Incorrect Message; Firing Problem

  IT WAS REPORTED THAT THE LASER WAS NOT FIRING, AND THE CONSOLE DISPLAYED AND ERROR MESSAGE INDICATING AUTO CALIBRATION WAS DISABLED DURING A PROCEDURE. THE PROCEDURE WAS CANCELED AS A RESULT. IT WAS NOTED THE PATIENT WAS UNDER SEDATION AT THE TIME OF THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR A CANCELLED/RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756075 ↗