AccuTrac M0068404110Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 08714729802716), received between May 25, 2017 and Nov 18, 2024 — classified as 4 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PREPARATION AFTER CONNECTING THE DEVICE TO THE HOST, THE FIBER HAD NO ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707900 ↗
• MalfunctionDec 13, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE THE FIBER COULD NOT WORK AND FELT HOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316013 ↗
• MalfunctionNov 17, 2023Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT DURING A PROCEDURE TO REMOVE A URETHRAL STONE, THE FIBER WAS OVERHEATING; IT WAS TOO HOT TO TOUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18157066 ↗
• MalfunctionMay 6, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ACCUTRAC LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A 100H LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER DID NOT PRODUCE LASER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 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. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306544 ↗
• MalfunctionMar 14, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ACCUTRAC SINGLE-USE HOLMIUM LASER FIBER WAS USED IN A KIDNEY STONE REMOVAL PROCEDURE TO TREAT KIDNEY STONES PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A AURIGA LASER CONSOLE. DURING THE PROCEDURE, THE BEAM ONLY LIT BRIEFLY BEFORE THE LASER FIBER GAVE A LOUD CRACK AND STOPPED WORKING. THE FIBER WAS CONNECTED AND DISCONNECTED SEVERAL TIMES TO TROUBLESHOOT THE PROBLEM. THE FIBER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC SINGLE-USE HOLMIUM 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 THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758498 ↗
• MalfunctionDec 14, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 23, 2021 THAT AN ACCUTRAC LASER FIBER WAS USED IN A URETERAL FLEXIBLE LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PLUGGED IN THE LASER FIBER, THE INTERFACE WAS HOT. THERE WAS NO BURN INJURY TO THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005557 ↗
• MalfunctionDec 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUTRAC 200 LASER FIBER WAS USED DURING A URETERAL FLEXIBLE LITHOTRIPSY TO TREAT CALCULUS OF THE KIDNEY ON (B)(6) 2021. THE LASER CONSOLE USED DURING THE PROCEDURE WAS A HOLMIUM LASER. DURING THE PROCEDURE, AFTER 10 TO 20 MINUTES OF USE, THE ACCUTRAC LASER FIBER CONNECTOR BECAME HOT AND BURNED THE PHYSICIAN. THE PHYSICIAN RECEIVED A MINOR BURN AND NO TREATMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 12940931 ↗
• MalfunctionMay 19, 2021Break; Degraded; Detachment of Device or Device Component; Break; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 15, 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A SOFT URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE UPPER CALYX PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. DURING THE PROCEDURE, THERE WAS NO ENERGY OUTPUT OF THE FIBER AND THE TIP OF THE FIBER BURNED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849641 ↗
• MalfunctionMay 17, 2021Break; Degraded; Detachment of Device or Device Component; Break; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-02282 FOR THE FIRST ACCUTRAC 200 LASER FIBER AND MFR. REPORT FOR THE SECOND ACCUTRAC 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6) 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A SOFT URETEROSCOPIC LITHOTRIPSY IN THE RENAL MIDDLE AND UPPER CALYX PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. DURING THE PROCEDURE, THERE WAS NO ENERGY DELIVERY FROM THE LASER FIBER. THE LASER FIBER TIP BURNED OUT. ANOTHER ACCUTRAC 200 LASER FIBER WAS USED AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838394 ↗
• MalfunctionMay 17, 2021Break; Degraded; Break; Degraded

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT FOR THE FIRST ACCUTRAC 200 LASER FIBER AND MFR. REPORT #3005099803-2021-02283 FOR THE SECOND ACCUTRAC 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC ON MARCH 15, 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A SOFT URETEROSCOPIC LITHOTRIPSY IN THE RENAL MIDDLE AND UPPER CALYX PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. DURING THE PROCEDURE, THERE WAS NO ENERGY DELIVERY FROM THE LASER FIBER. THE LASER FIBER TIP BURNED OUT. ANOTHER ACCUTRAC 200 LASER FIBER WAS USED AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838392 ↗
• MalfunctionMar 1, 2021Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE WITH THE LASER SETTINGS OF 0.5 JOULES, 40 HERTZ AND 20 WATTS. IT WAS REPORTED, DURING PROCEDURE, THERE WAS NO ENERGY TRAVELING THROUGH THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396459 ↗
• MalfunctionFeb 17, 2021Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 19, 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A URETERAL FLEXIBLE LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER WITH THE LASER SETTINGS OF 20-30 WATTS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE FIBER CONNECTOR WAS HEATED AFTER THE FIBER WAS CONNECTED TO THE CONSOLE. THE PHYSICIAN GOT BURNT. REPORTEDLY, THE PHYSICIAN'S BURN WAS TREATED WITH AN ICE COMPRESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

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

  MAUDE report 11337375 ↗
• MalfunctionFeb 9, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 19, 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A LITHOTOMY UNDER FLEXIBLE URETEROSCOPE PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE WITH THE LASER SETTINGS OF 20 TO 30 WATTS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR A PROCEDURE, THE FIBER CONNECTOR WAS HEATED AFTER THE FIBER WAS CONNECTED TO THE CONSOLE. THE PHYSICIAN GOT BURNT. REPORTEDLY, THE PHYSICIAN'S BURN WAS TREATED WITH AN ICE COMPRESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

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

  MAUDE report 11300662 ↗
• MalfunctionFeb 9, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A LITHOTOMY UNDER FLEXIBLE URETEROSCOPE PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6), 2021. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE WITH THE LASER SETTINGS OF 20 TO 30 WATTS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE FIBER CONNECTOR HEATED AFTER THE FIBER WAS CONNECTED TO THE CONSOLE. THE PHYSICIAN GOT BURNT. REPORTEDLY, THE PHYSICIAN'S BURN WAS TREATED WITH AN ICE COMPRESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

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

  MAUDE report 11300568 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A HOLMIUM LASER LITHOTRIPSY WITH TRANSURETHRAL URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THERE WAS NO INDICATOR LIGHT FROM THE LASER FIBER AFTER CONNECTING TO THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11078260 ↗
• MalfunctionOct 14, 2020Break; Failure to Fire; Break; Failure to Fire

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2020-04490 FOR THE FIRST ACCUTRAC 200 LASER FIBER, MFR. REPORT # 3005099803-2020-04491 FOR THE SECOND ACCUTRAC 200 LASER FIBER AND MFR. REPORT # 3005099803-2020-04492 FOR THE THIRD ACCUTRAC 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 31, 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL, THERE WAS NO ENERGY TRAVELING THROUGH THE FIBER. A SECOND AND THIRD OF THE SAME DEVICE WERE OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10676743 ↗
• MalfunctionOct 13, 2020Break; Failure to Fire; Detachment of Device or Device Component; Break; Failure to Fire; Detachment of Device or Device Component

  THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2020-04490 FOR THE FIRST ACCUTRAC 200 LASER FIBER, MFR. REPORT # 3005099803-2020-04491 FOR THE SECOND ACCUTRAC 200 LASER FIBER AND MFR. REPORT # 3005099803-2020-04492 FOR THE THIRD ACCUTRAC 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL, THERE WAS NO ENERGY TRAVELING THROUGH THE FIBER. A SECOND AND THIRD OF THE SAME DEVICE WERE OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC CORPORATIONHAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR, FIBER BODY BROKE AND FIBER TIP DETACHED. PLEASE SE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10673007 ↗
• MalfunctionOct 13, 2020Break; Failure to Fire; Break; Failure to Fire

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #: 3005099803-2020-04490 FOR THE FIRST ACCUTRAC 200 LASER FIBER, MFR REPORT #: 3005099803-2020-04491 FOR THE SECOND ACCUTRAC 200 LASER FIBER AND MFR. REPORT #: 3005099803-2020-04492 FOR THE THIRD ACCUTRAC 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL, THERE WAS NO ENERGY TRAVELING THROUGH THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. A SECOND AND THIRD OF THE SAME DEVICE WAS OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER WAS BROKEN WITHIN T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10672211 ↗
• MalfunctionAug 4, 2020Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A ACCUTRAC 200 LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE FOR A STONE IN THE URETER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER 20 WATT LASER CONSOLE WITH THE LASER SETTINGS OF 1 JOULE AND 20 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE SCOPE AND MISFIRED DURING LASER ACTIVATION. IT ALSO DAMAGED THE SCOPE. REPORTEDLY, THE TIP FRAGMENT WAS INSIDE THE SCOPE AND NO FIBER FRAGMENTS FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362960 ↗
• MalfunctionJul 29, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6), 2020. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER 20 WATT LASER CONSOLE WITH LASER SETTINGS OF 1500 MILLIJOULES AND 10 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE ABOUT 6 TO 7 INCHES FROM THE PROXIMAL TIP INSIDE THE SCOPE. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE FRAGMENT WAS INSIDE THE SCOPE WHEN REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10340029 ↗
• MalfunctionApr 20, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 31, 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE FOR A STONE IN THE KIDNEY PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CONNECTOR OF THE LASER FIBER WAS HOT AND COULD NOT BE USED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9976978 ↗
• MalfunctionMar 31, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 10, 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS OPENED FOR USE FOR A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, UPON REMOVING THE FIBER OUT OF THE COIL IT WAS NOTED THAT THE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9907838 ↗
• MalfunctionFeb 26, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 3, 2020 THAT AN ACCUTRAC 200 LASER FIBER WAS USED IN A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER DID NOT WORK PROPERLY AND THE FIBER CONNECTOR BECAME HOT AND WOULD NOT BREAK UP STONES. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756793 ↗
• MalfunctionFeb 10, 2020Degraded; Optical Problem; Degraded; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 30, 2019 THAT A ACCUTRAC 200 LASER FIBER WAS USED IN AN URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER SETTINGS OF 40 WATTS, 1.0 JOULES AND 40 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AIMING BEAM WAS NOTED TO BE NOT VISIBLE AND THE LASER FIBER STOPPED FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE SMA CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687809 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT ACCUTRAC 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE LASER FIBER BROKEN DURING INSERTION. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530896 ↗