VersaPulse PowerSuite VersaPulse PowerSuite 100W (REF RG0638-803-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07290109145853), received between Sep 9, 2022 and Feb 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE WAS PRESENTING LOW WATTAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335055 ↗
• MalfunctionJan 29, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING CAPITAL EQUIPMENT MAINTENANCE THE CONSOLE OPTICS HAD AN ENERGY DELIVERY OUTPUT/FAILURE DUE TO THE LASER CONSOLE WAS PROVIDING LOW WATTAGE. THIS LASER IS USED TO TEST BSC PRODUCTS. NO FOR HUMAN USE. THERE WAS NO PATIENT INVOLVED. THIS EVENT IS BEING REPORTED FOR LOW POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210401 ↗
• MalfunctionNov 26, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE IS HAVING LOW POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659192 ↗
• MalfunctionJun 20, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING SETUP, THE CONSOLE WAS FOUND WITH LOW POWER OUTPUT AND DID NOT PRESENT ANY ERRORS OR CASE SERVER MODE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301735 ↗
• MalfunctionApr 24, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC URETEROSCOPY AND INSERTION OF STENT PROCEDURE, WHEN THE FIBER WAS INSERTED INTO THE CONSOLE, IT SWITCHED OFF. IT WAS TRIED TO USE ANOTHER FIBER AND ALSO TRIED ANOTHER FIBER FROM A DIFFERENT LOT NUMBER, BUT THE CONSOLE SHUT DOWN IN BOTH ATTEMPTS. THE PATIENT WAS UNDER GENERAL ANESTHESIA BUT THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS CANCELLED. 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 19177273 ↗
• MalfunctionMay 29, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED AN ERROR INDICATING THAT THE DEVICE OVERHEATED. THEREFORE, THE PROCEDURE WAS CANCELLED. 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 17017452 ↗
• MalfunctionNov 29, 2022Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE CONSOLE AUTOMATICALLY SHUT DOWN. THE MEDICAL ENGINEERING DEPARTMENT WITHIN THE HOSPITAL WAS CONTACTED. THE ENGINEER WAS ABLE TO RESTART THE CONSOLE AND RETURN IT TO NORMAL OPERATION. THE PROCEDURE WAS COMPLETED USING THIS DEVICE WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877584 ↗
• MalfunctionNov 9, 2022Defective Device; Noise, Audible; Defective Device; Noise, Audible

  IT WAS REPORTED THAT, DURING A PROCEDURE, DAMAGE TO THE FIBER AND DEBRIS SHIELD WAS OBSERVED, ALONG WITH A NOISE WHEN FIRING. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS RESCHEDULED AFTER ATTEMPTING TO USE ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765291 ↗
• MalfunctionOct 27, 2022Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT THE LASER MADE A NOISE AND THEN THE SCREEN DISPLAYED RED. ERROR LOG SHOWED ERROR 504. THE PHYSICIAN WAS UNABLE TO USE THE LASER FOR THE PROCEDURE. 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 15686485 ↗
• MalfunctionOct 18, 2022Noise, Audible; Physical Resistance/Sticking; Noise, Audible; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FOOT SWITCH PEDAL OF THIS CONSOLE WOULD STICK AND CONTINUE FIRING WHEN PRESSED; A RATTLING SOUND WAS ALSO HEARD WITHIN THE FOOT SWITCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629686 ↗
• MalfunctionSep 9, 2022Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONSOLE PEDAL STICKS AND CONTINUES TO FIRE EVEN WHEN THE SURGEON REMOVES HIS LEG FROM THE PEDAL. THERE IS ALSO A RATTLING SOUND INSIDE THE FOOTSWITCH. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396511 ↗