Lumenis Pulse 120H (REF GA-0006900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07290109145402), received between Oct 27, 2022 and Apr 20, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Mechanical Problem; Power Conditioning Problem; Failure to Power Up; Smoking; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CONSOLE SMELLS BURNT AND THE POWER WENT OUT BECAUSE THE BREAKER TRIPPED. IT WAS ATTEMPTED TO ACCESS THE LOG FILES, BUT THE CONSOLE WOULD NOT TURN ON. LATER, IT WAS CONFIRMED THAT THE CONSOLE HAD DISPLAYED ERROR CODES 204 (CHARGER ERROR-CHARGER GENERAL FAILURE), 256 (LASING AND SAFETY-CAPACITORS VOLTAGE FAIL BEFORE PULSE DELIVERED), 86 (BRICK 4 LAMP HAS AGED) AND 80 (FAILED TO CALIBRATED BRICK 2). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933139 ↗
• MalfunctionJan 29, 2026Output below Specifications

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210069 ↗
• MalfunctionJan 6, 2026Communication or Transmission Problem

  It was reported that, the console issued error codes 58 (Self-test process failure (one of the tests completed with fail status)) and 142 (External Indicator, Foot switch SW1 status fail) during preparation. The procedure was cancelled 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 23974312 ↗
• MalfunctionDec 17, 2025Output below Specifications; Noise, Audible; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT, THE POWER DON'T HAVE ENOUGH POWER TO BREAK THE STONES AND MAKES A STRANGE NOISE. THE PROCEDURE WAS CANCELLED/RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830705 ↗
• MalfunctionOct 21, 2025Degraded; Output below Specifications; Degraded; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD A LOW PERFORMANCE OR POWER. IN ADDITION, IT WAS NOTED THAT ERROR CODE 83 (BRICK 1 LAMP HAS AGED) WAS PROMPTED. NO FURTHER INFORMATION WAS REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PROCEDURE AND/OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349745 ↗
• MalfunctionAug 28, 2025Energy Output Problem; Smoking; Energy Output Problem; Smoking

  IT WAS REPORTED THAT THERE WAS A BURNING SMELL COMING FROM THE BACK OF THE CONSOLE AND THERE WERE ENERGY ISSUES. ALSO, THE CONSOLE BURNED THREE FIBERS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22918152 ↗
• MalfunctionJul 4, 2025Smoking; Defective Device; Smoking; Defective Device

  IT WAS REPORTED THAT THERE WAS A BURNING SMELL COMING FROM THE LASER. THE FIBER WAS BURNED DUE TO THE DEBRIS SHIELDS BEING BURNT. THE PROCEDURE WAS NOT COMPLETED, AND WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403714 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE JOURNAL OF ENDOUROLOGY THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO DETERMINE WHETHER A SHORT-TERM PB (PROSTATE BIOPSY) BEFORE HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) HAS AN IMPACT ON THE PERIOPERATIVE OUTCOMES OR COMPLICATIONS OF HOLEP. A TOTAL OF 734 PATIENTS WHO WERE TREATED BY HOLEP PROCEDURE WERE ENROLLED FROM JANUARY 2021 TO JULY 2023. THE FOLLOWING BOSTON SCIENTIFIC PRODUCTS WERE USED DURING THE PROCEDURES: LUMENIS PULSE 120H HOLMIUM-LASER SYSTEM. INTRAOPERATIVELY, SOME PATIENTS EXPERIENCED UNDERMINING BLADDER NECK AND PERFORATIONS OF THE CAPSULE. ONE PATIENT REQUIRED A REINTERVENTION, 60 PATIENTS EXPERIENCED POST-OPERATIVE AUR (ACUTE URINARY RETENTION), 9 MORE PATIENTS REQUIRED BLOOD TRANSFUSION. THE STUDY CONFIRMED THAT 87 PATIENTS PRESENTED PROLONGED MACROHEMATURIA; 57 PATIENT DEVELOPED URINARY TRACT INFECTION, AND IT WAS NEEDED ADMINISTRATION OF ANTIBIOTICS. FINALLY, THE STUDY CONFIRMED 16 PATIENTS REQUIRED ENDOSCOPIC HEMOSTASIS UNDER GENERAL ANESTHESIA AND 6 PATIENTS UNDERWENT A RADIOLOGICAL CATHETER INSERTION. IT IS CONCLUDED THAT THE PB LESS THAN 6 MONTHS BEFORE HOLEP DID NOT AFFECT PERIOPERATIVE OUTCOMES OR COMPLICATIONS. THE NECESSITY

  Patient problems: Hematuria; Perforation; Unspecified Tissue Injury; Urinary Retention; Urinary Tract Infection

  MAUDE report 22091616 ↗
• MalfunctionApr 21, 2025Smoking; Output below Specifications; Smoking; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE HAD A CASE SAVER MODE AND A BURNING SMELL. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872857 ↗
• MalfunctionMar 26, 2025Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER BROKE DOWN AS IT MADE NOISES AND HAD A BURNING SMELL. THE LASER DID NOT BOOT. THE PROCEDURE WAS COMPLETED USING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702736 ↗
• MalfunctionFeb 27, 2025Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONSOLE KEPT FIRING EVEN IF THE PEDAL WAS NOT PRESSED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21484214 ↗
• MalfunctionFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Output below Specifications; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT THE LASER DEVICE HAD NOISE AND A LOW OUTPUT ENERGY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361761 ↗
• MalfunctionJan 2, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE SYSTEM WILL NOT BOOT UP. THERE WERE NO ERROR MESSAGES. THERE WAS NO PATIENT OUTCOME REPORTED. THE PROCEDURE WAS RESCHEDULED. 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 21053860 ↗
• MalfunctionAug 29, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED ERRORS 253 AND 273. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 20103910 ↗
• InjuryJun 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A NURSE BURNED THEIR HAND WHILE USING THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED REGARDING A DEVICE MALFUNCTION OR OUTCOME OF THE BURN.

  Patient problems: Burn(s)

  MAUDE report 19558698 ↗
• MalfunctionSep 11, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Output below Specifications; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT, DURING THE PROCEDURE, ERROR 64 WAS RECEIVED, CASE SAVER MODE WAS ACTIVATED, AND THE CONSOLE HAD LOW POWER. THE PATIENT HAD BEEN ADMINISTERED A REGIONAL ANESTHESIA IN PREPARATION FOR THE PROCEDURE. AS A RESULT OF THE DEVICE ISSUES, THE PROCEDURE WAS ABORTED. 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 17722135 ↗
• MalfunctionAug 29, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT WHEN THE CONSOLE WAS STARTED, IT ENGAGED THE ELECTRICAL SECURITY SYSTEM. THE POWER CORD WAS FOUND TO BE GOOD CONDITION, BUT THE R1 ON THE AC BOARD COMPONENTS WERE BURNT. THE PATIENT WAS UNDER SEDATION AT THE TIME AND NO PROCEDURE WAS PERFORMED DUE TO THIS PROBLEM. THERE WAS NO PATIENT COMPLICATION. 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 17647178 ↗
• InjuryMar 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE TO LASE A STONE, A RED FLASHING WAS OBSERVED WHICH CONCERNED THE PHYSICIAN. THE FIELD REPRESENTATIVE NOTED THAT THIS FLASHING HAS BEEN SEEN BEFORE; SHE STATED IT COULD BE CAUSED BY AN INTERACTION BETWEEN THE LASER AND THE STONE OR THE CAMERA OR INTERFERENCE FROM LASER COMPONENTS. IT WAS REPORTED THAT, FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED AN UNSPECIFIED ADVERSE REACTION. IT WAS NOT KNOWN WHETHER THE PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION.

  Patient problems: Insufficient Information

  MAUDE report 16616888 ↗
• MalfunctionFeb 7, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE DEVICE DISPLAYED ERRORS 253 AND 273, THE BLEEDING WAS STOPPED USING AN ALTERNATE DEVICE AND THE PROCEDURE WAS CANCELED. THERE WAS NO REPORTED PERMANENT IMPAIRMENT OR INJURY TO THE PATIENT THIS EVENT IS BEING REPORTED FOR A CANCELLED PROCEDURE WITH THE PATIENT UNDER SEDATION OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312326 ↗
• MalfunctionJan 19, 2023Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE STARTED TO RATTLE LOUDLY AND A SCORCHED SMELL WAS DETECTED. THE PHYSICIAN WAS NOT ABLE TO LASER ANY LONGER SO THE PROCEDURE WAS ABORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED PROCEDURE WITH THE PATIENT UNDER GENERAL ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16211083 ↗
• MalfunctionOct 27, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING PREPARATION FOR A HOLEP PROCEDURE THE LASER WAS NOT FUNCTIONING, AND THE PATIENT WAS PRESENT AND SEDATED. THE LASER WOULD NOT POWER UP AND THERE WAS NO ERROR SHOWING. TRIED TROUBLESHOOTING THE ISSUE AND WAS UNSUCCESSFUL AND THE PROCEDURE WAS CANCELED. THERE WAS NO PATIENT COMPLICATION THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685244 ↗