Flexiva TracTip M0068403960Recalls & reported problems

Summary

The FDA's MAUDE database contains 562 adverse event reports that list this exact device (DI 08714729808169), received between Feb 1, 2017 and Feb 10, 2025 — classified as 40 injuries, 522 malfunctions.

The most frequently reported specific device problem is “Break” (386 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 562 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING INSERTION, THE FIBER BROKE TWO SEPARATE TIMES. IT WAS NOTED THAT THE FIBER SNAPPED IN TWO WITHOUT CATCHING ANYTHING FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351553 ↗
• MalfunctionApr 16, 2024Incomplete or Missing Packaging; Adverse Event Without Identified Device or Use Problem; Packaging Problem; Incomplete or Missing Packaging; Adverse Event Without Identified Device or Use Problem; Packaging Problem

  IT WAS REPORTED THAT THE FIBER PACKAGING APPEARED TO BE USED. THE BOX APPEARED TO BE OLD, CRUSHED, AND THE SEAL APPEARED TO HAVE BEEN OPENED. NO FURTHER INFORMATION WAS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122566 ↗
• MalfunctionDec 19, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BOTTOM OF THE STERILE PACKAGING WAS NOT SEALED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360872 ↗
• MalfunctionJul 28, 2023Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FRACTURE WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414210 ↗
• MalfunctionAug 5, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASER FIBER WAS CONNECTED TO THE LASER CONSOLE AND UPON PRESSING DOWN THE FOOT PEDAL IT DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178237 ↗
• MalfunctionAug 3, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASER FIBER WAS ATTACHED TO THE LASER CONSOLE AND DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156055 ↗
• MalfunctionJun 1, 2022Break; Break

  A FLEXIVA TRACTIP LASER FIBER WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION. THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE DEVICE WAS ANALYZED AND THE INVESTIGATION RESULTS REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569281 ↗
• MalfunctionMay 24, 2022Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 2, 2022 THAT A FLEXIVA TRACTIP LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE FOR A STONE TREATMENT IN THE URETER PERFORMED ON (B)(6) 2022. THE LASER CONSOLE UNIT USED WAS A P100 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS NOT WORKING WELL ON THE STONE. THE NURSE WENT TO CHANGE THE LASER FIBER AND BURNT HER THUMB FROM THE FIBER CONNECTOR. THE NURSE HAD TWO SMALL BLISTERS AND WAS TREATED AT HOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487843 ↗
• MalfunctionMay 19, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE-USE LASER FIBER WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FAILED TO FIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437921 ↗
• MalfunctionApr 20, 2022Degraded; Overheating of Device; Optical Problem; Degraded; Overheating of Device; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THE FIBER CONNECTOR WAS WARM TO TOUCH AND THE AIMING BEAM WAS POOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162217 ↗
• MalfunctionApr 15, 2022Break; Degraded; Material Integrity Problem; Break; Degraded; Material Integrity Problem

  REFER TO THIS REPORT FOR THE FIRST FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER, MFR REPORT # 3005099803-2022-02044 FOR THE SECOND FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT TWO FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBERS WERE USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBERS WORKED FOR A FEW FIRES THEN STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121441 ↗
• MalfunctionApr 15, 2022Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASER FIBER WAS NOT WORKING AND THE CONNECTOR WAS WARM TO THE TOUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121440 ↗
• MalfunctionApr 15, 2022Break; Degraded; Material Integrity Problem; Break; Degraded; Material Integrity Problem

  REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2022-02043 FOR THE FIRST FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER, THIS REPORT FOR THE SECOND FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT TWO FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBERS WERE USED DURING A PROCEDURE, PERFORMED ON (B)(6)2021. DURING THE PROCEDURE, THE LASER FIBERS WORKED FOR A FEW FIRES THEN STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121435 ↗
• MalfunctionApr 13, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER STONE EXTRACTION PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A QUANTA CYBER HO LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14091705 ↗
• MalfunctionApr 12, 2022Break; Optical Problem; Break; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, THERE WAS NO LIGHT COMING OUT OF THE LASER FIBER WHEN CHECKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14091156 ↗
• MalfunctionApr 12, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 27, 2021 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER STOPPED FIRING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14085014 ↗
• MalfunctionApr 12, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083387 ↗
• MalfunctionApr 12, 2022Break; Optical Problem; Break; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A SWISS LASERCLAST CONSOLE WITH A LASER SETTING OF 10 WATTS. DURING THE PROCEDURE, THE AIMING BEAM OF THE LASER FIBER WAS WEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083383 ↗
• MalfunctionApr 8, 2022Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 31, 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE TO TREAT UROLITHIASIS , PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FLEXIVA TRACTIP WAS NOT RECOGNIZED BY THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052971 ↗
• MalfunctionApr 7, 2022Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 16, 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED IN A LASER LITHOTRIPSY & TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE TO TREAT STONES IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER SPLIT APART AND CAUSED THE FIBER CONNECTOR TO OVERHEAT. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT AND NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 14048431 ↗
• MalfunctionApr 7, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 14, 2021 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER WORKED FINE FOR MOST OF THE CASE THEN SUDDENLY STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14042657 ↗
• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 10, 2022 THAT A FLEXIVA TRACTIP LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN DISPLAYED ON CAMERA, THE TIP OF THE LASER FIBER APPEARED TO BE DIFFERENT FROM THE USUAL BALL-TIP. THE LASER FIBER WAS REMOVED AND CUT, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL FLEXIVA TRACTIP LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: ALTHOUGH THE FLEXIVA LASER FIBER TIP WAS FOUND TO BE DIFFERENT FROM THE USUAL BALL-TIP, THE USER CHOSE TO CUT THE FIBER AND CONTINUE USE. THE FLEXIVA TRACTIP LASER FIBER IFU DIRECTS THE USER TO ENSURE THE PRODUCT IS NOT DAMAGED AS PART OF DEVICE PREPARATION AND TO NOT USE THE DEVICE IF IT IS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978345 ↗
• InjuryMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT A STONE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE INSIDE THE PATIENT. THE LASER FIBER TIP WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870711 ↗
• InjuryMar 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE-USE LASER FIBER WAS USED IN A PROCEDURE TO TREAT A STONE IN THE KIDNEY PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE LASERING THE KIDNEY STONE, THE TIP OF THE LASER FIBER BROKE OFF IN THE KIDNEY. THE FIBER TIP WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13845639 ↗
• InjuryMar 16, 2022Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 18, 2022 THAT A FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER WAS USED DURING A CYSTO BILATERAL URETEROSCOPY PROCEDURE TO TREAT KIDNEY STONES OF THE KIDNEY, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE WITH LASER SETTINGS OF 0.5 MILLIJOULES AND 50 HERTZ ON THE LEFT KIDNEY AND 0.08 MILLIJOULES AND 50 HERTZ ON THE RIGHT KIDNEY WITH TOTAL ENERGY OF 40. DURING THE PROCEDURE, THE FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER STOPPED WORKING WELL AFTER BEING USED FOR SEVENTEEN MINUTES. THE TECH ATTEMPTED TO MAKE SURE THE FIBER WAS FULLY CONNECTED AND FOUND THE METAL LASER FIBER CONNECTOR WAS HOT. SHE BURNED HER FINGERS WHEN SHE TOUCHED THE LASER FIBER CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA TRACTIP HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND IT WAS UNKNOWN WHETHER ANY TREATMENT WAS REQUIRED FOR THE BURN TO THE TECHS FINGERS.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789788 ↗