GreenLight HPS 0010-2090Recalls & reported problems

Summary

The FDA's MAUDE database contains 292 adverse event reports that list this exact device (DI 00878953004709), received between Aug 30, 2017 and Aug 14, 2026 — classified as 7 injuries, 285 malfunctions.

The most frequently reported specific device problem is “Break” (164 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 25 most recent of 292 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Break

  It was reported that the fiber tip broke. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255914 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225943 ↗
• MalfunctionApr 28, 2026Nonstandard Device; Peeled/Delaminated

  IT WAS REPORTED THAT THE FIBER TIP PEELED AFTER 5 MINUTES OF USE WHEN THE SURGEON PULLED THE FIBER BACK INSIDE THE OPTICAL HANDLE LUMEN. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017877 ↗
• MalfunctionApr 7, 2026Nonstandard Device

  IT WAS REPORTED THAT THE FIBER WAS RETURNED WITHOUT PERFORMANCE ALLEGATION INFORMATION. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE GLASS TIP WAS BROKEN AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801724 ↗
• MalfunctionMar 30, 2026Nonstandard Device; Connection Problem

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE THE FIBER WAS NOT RECOGNIZE. THE FIBER WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE FIBER TIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717776 ↗
• MalfunctionMar 5, 2026Firing Problem

  IT WAS REPORTED THAT, THE CONNECTION FAILED ONCE AND THEN THE FIBER WAS UNPLUGGED AND PLUGGED BACK IN AND WORKED. THE LASER BEAM WAS BEING EMITTED FROM THE TIP RATHER THAN LATERALLY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520435 ↗
• MalfunctionFeb 27, 2026Break; Peeled/Delaminated

  IT WAS REPORTED THAT THE FIBER BROKE INTRAOPERATIVELY AT ITS DISTAL END AFTER 14 MINUTES WHEN THE SURGEON RETRACTED IT INTO THE FIBER HOLDER. THE FIBER TIP ALSO PEELED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471414 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT, DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, WHEN THE PROCEDURE WAS STARTED GREEN LIGHT APPEARED IN THE OUT-CORE OF THE FIBER LINE. THERE WAS NO EFFECT ON THE TISSUE, AND THERE WAS NO LASER OUTPUT FROM THE FIBER TIP. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING A NEW FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372975 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING THE PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, WHEN THE PROCEDURE WAS STARTED GREEN LIGHT WAS OBSERVED IN THE OUTCORE OF THE FIBER LINE, BUT THERE WAS NO EFFECT ON THE TISSUE. NO ENERGY WAS EMITTED FROM THE FIBER TIP WHILE THE PHYSICIAN WAS ATTEMPTING VAPORIZATION. AS A RESULT, THE FIBER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300372 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE, THE FIBER TIP BROKE AFTER 13 MINUTES AND 50 SECONDS OF USE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052826 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FIBER BROKE OFF AFTER USING 218810 JOULES AND 10 MINUTES WITH 41 SECONDS OF FIBER USE. IT WAS NOTED THAT THE FIBER BREAK OCCURRED AT 0.5 CM FROM THE TIP. THE FIBER PIECE WAS RETRIEVED USING FORCEPS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722434 ↗
• MalfunctionSep 12, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE FIBER WAS DAMAGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040295 ↗
• MalfunctionAug 25, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE FIBER STOPPED WORKING. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE ANALYSIS OF THE RETURNED DEVICE DID IDENTIFY A FIBER BODY BREAK BETWEEN THE CONTROL KNOB AND THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890975 ↗
• MalfunctionAug 14, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE, AFTER USING (B)(4) JOULES AND 1 MINUTE AND 46 SECONDS OF FIBER USE, FORWARD FIRING OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806472 ↗
• MalfunctionAug 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Firing Problem; Break; Adverse Event Without Identified Device or Use Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FIBER TIP BROKE AT 28,203 JOULES AND 3:39 MINUTES OF USE AND THEN FORWARD FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710055 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, AFTER USING 29688 JOULES AND 11 MINUTES AND 6 SECONDS OF FIBER USE, THERE WAS A METAL TIP RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708486 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, AFTER USING 10358 JOULES, AND 2 MINUTES AND 8 SECONDS OF FIBER USE, THERE WAS A METAL TIP RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688482 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER WAS RETURNED WITH NOT EXISTING COMPLAINT. LABORATORY ANALYSIS OF THE RETURNED IDENTIFIED THAT THE GLASS CAP WAS CRACKED AND THE OUTER FLOW TUBING APPEARED TO BE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650524 ↗
• MalfunctionJul 24, 2025Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE FIBER WAS OVERHEATED AND STOPPED WORKING AFTER 9:57 MINUTES AND 31034 JOULES USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS. THE FIBER WAS RETURNED AND THE ANALYSIS REVEALED THAT THE GLASS CAP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22595815 ↗
• MalfunctionJun 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS INTERRUPTED DUE TO MACHINE TROUBLE DURING THE PROCEDURE. AS IT WAS POSSIBLE THAT THE PROBLEM WAS WITH THE HPS FIBER, THE PROBLEM WAS NOT RESOLVED EVEN AFTER REPLACING IT WITH ANOTHER LOT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT SEDATION STATUS WAS NOT REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328081 ↗
• MalfunctionJun 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS INTERRUPTED DUE TO A FIBER PROBLEM. THE FIBER WAS REPLACED, BUT THE ISSUE PERSISTED. 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 22297598 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A POSTER PRESENTED AT THE 112TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION THAT A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 929 PATIENTS WHO UNDERWENT PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) FOR BENIGN PROSTATIC HYPERPLASIA (BPH) BETWEEN NOVEMBER 2011 AND MARCH 2024 TO IDENTIFY REOPERATION RATES, TYPES OF SURGERIES, AND RISK FACTORS FOR REOPERATION DURING LONG-TERM FOLLOW-UP. THE MEDIAN PATIENT AGE WAS 73 YEARS, WITH A MEDIAN PREOPERATIVE PSA OF 4.0 ML/DL AND A MEDIAN PROSTATE VOLUME OF 50 ML. THE MEDIAN FOLLOW-UP PERIOD WAS 923 DAYS. THE OVERALL REOPERATION RATE WAS 10.1%, WITH VARIOUS TYPES OF REOPERATIONS INCLUDING TRANSURETHRAL HEMOSTASIS, PVP FOR PROSTATIC HYPERPLASIA, TURP, URETHRAL DILATION FOR BLADDER NECK SCLEROSIS, AND TRANSURETHRAL CYSTOLITHOTRIPSY FOR BLADDER STONES. ONE PERCENT OF PATIENTS UNDERWENT RADICAL PROSTATECTOMY DUE TO A SUBSEQUENT DIAGNOSIS OF PROSTATE CANCER. NO SIGNIFICANT DIFFERENCES IN AGE, PSA, ENERGY, PROSTATE VOLUME, OR SURGERY TIME WERE FOUND BETWEEN THE REOPERATION AND NON-REOPERATION GROUPS, ALTHOUGH A LONGER FOLLOW-UP PERIOD WAS ASSOCIATED WITH A HIGHER LIKELIHOOD OF REOPERATION FOR PROSTA

  Patient problems: Stenosis

  MAUDE report 22030712 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FIBER BROKE AFTER NINE MINUTES AND 14,000 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985744 ↗
• MalfunctionApr 10, 2025Melted; Melted

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FIBER TIP MELTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21821036 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FIBER BROKE WHILE BEING USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371825 ↗