Litho 150 PVMS00062Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08059173391738), received between Oct 20, 2021 and Mar 24, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THEY BELIEVE LASER WAS NOT FUNCTIONING PROPERLY AND DETERMINED TO PULL IT OUT OF SERVICE UNTIL A TECHNICIAN COULD LOOK AT IT. COMPLAINANT REPORTED THEY BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS. ATTENDEE BELIEVED IT WAS RELATED TO A FW UPDATED WHICH HAD BEEN DONE THE DAY PRIOR. PROCEDURE WAS COMPLETED AS BIPOLAR WAS USED TO CONTROL BLEEDING. PATIENT WAS ADMITTED OVERNIGHT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24680244 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THEY BELIEVE LASER WAS NOT FUNCTIONING PROPERLY AND DETERMINED TO PULL IT OUT OF SERVICE UNTIL A TECHNICIAN COULD LOOK AT IT. COMPLAINANT REPORTED THEY BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS. ATTENDEE BELIEVED IT WAS RELATED TO A FW UPDATED WHICH HAD BEEN DONE THE DAY PRIOR. PROCEDURE WAS COMPLETED AS BIPOLAR WAS USED TO CONTROL BLEEDING. PATIENT WAS ADMITTED OVERNIGHT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24680241 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THEY BELIEVE THE LASER WAS NOT FUNCTIONING PROPERLY AND PATIENT WAS READMITTED OVER THE WEEKEND FOR BLEEDING FOLLOWING HOLEP PROCEDURE. COMPLAINANT BELIEVES LASER MAY BE THE CAUSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24680128 ↗
• InjuryMar 11, 2026Insufficient Device Problem Information

  THIS REPORT CONCERNS TWO CASES OF DELAYED POSTOPERATIVE HEMORRHAGE FOLLOWING HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURES, NOTIFIED BY DISTRIBUTOR ON 03/05/2026. BOTH PATIENTS REQUIRED EMERGENCY READMISSION ON THE FIRST POSTOPERATIVE NIGHT DUE TO GROSS HEMATURIA AND OBSTRUCTIVE CLOT FORMATION. IN BOTH INSTANCES, SURGICAL INTERVENTION USING A BIPOLAR ROLLER BALL WAS NECESSARY TO MANAGE THE BLEEDING AND EVACUATE THE CLOTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24574555 ↗
• MalfunctionNov 24, 2022Break; Break

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860272 ↗
• MalfunctionSep 1, 2022Energy Output Problem; Energy Output Problem

  LOW LASER ENERGY ERROR APPEARING ON THE SCREEN. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334933 ↗
• MalfunctionSep 1, 2022Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334924 ↗
• MalfunctionJul 25, 2022Energy Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15091711 ↗
• MalfunctionJul 20, 2022Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064810 ↗
• MalfunctionJun 16, 2022Defective Device

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711269 ↗
• MalfunctionApr 21, 2022Defective Device

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166135 ↗
• MalfunctionFeb 11, 2022Therapeutic or Diagnostic Output Failure

  THE LASER DEVICE HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13512205 ↗
• MalfunctionNov 25, 2021Electrical /Electronic Property Problem; Defective Component; Electrical /Electronic Property Problem; Defective Component

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873631 ↗
• MalfunctionNov 4, 2021Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Defective Component; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750409 ↗
• MalfunctionOct 20, 2021Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664356 ↗