Flexiva™ ID TracTip M006R8403960Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 08714729963837), received between Feb 21, 2018 and May 7, 2022 — classified as 11 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Break” (125 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT FLEXIVA ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. 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 14317883 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS NOT FIRING ANY ENERGY FROM THE TIP. THE LASER FIBER WAS SCREWED IN ALL THE WAY INTO THE CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION: 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 12594559 ↗
• MalfunctionSep 1, 2021Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A MOSES 2.0 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS NOT WORKING UPON PRESSING DOWN THE FOOT PEDAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR AND FIBER BODY BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411157 ↗
• MalfunctionSep 1, 2021Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER DID NOT WORK. 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. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BODY BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 12410758 ↗
• MalfunctionSep 1, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE LASER UNIT USED WAS A LUMENIS MOSES LASER CONSOLE. DURING THE PROCEDURE, THERE WAS NO LASER ENERGY COMING OUT FROM THE TIP OF THE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: 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 12410545 ↗
• MalfunctionAug 27, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 3, 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A CYSTOSCOPY, RIGHT RETROGRADE URETEROGRAM AND PYELOGRAM, RIGHT PYELOSCOPY WITH LASER LITHORTIPSY AND PLACEMENT OF A 6X24 DOUBLE-J URETERAL STENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER WAS NOT WORKING PROPERLY AND THE HUB WHERE THE FIBER WAS ATTACHED TO THE SURGICAL LASER SYSTEM WAS HEATING UP. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380159 ↗
• MalfunctionAug 18, 2021Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 27, 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER HAD NO AIMING BEAM AND DID NOT FIRE. THE LASER WAS UPLUGGED AND THE END OF THE LASER FIBER WAS EXTREMELY HOT. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339723 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, 1.5 CM FROM THE WORKING END OF THE FIBER TIP WAS BENT/BROKEN. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300572 ↗
• InjuryJul 20, 2021Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2021 FOR KIDNEY STONE TREATMENT. REPORTEDLY, A P100 CONSOLE WAS USED WITH SETTINGS OF 1 JOULE AND 53 HERTZ. DURING THE PROCEDURE THE LASER FIBER BEGAN TO DIM AND LITTLE ENERGY WAS BEING EMITTED. THE OPERATOR UNSCREWED THE FIBER AND NOTICED THE CONNECTOR WAS VERY HOT. REPORTEDLY, THE OPERATOR BURNED HIS FINGER ON THE FIBER CONNECTOR BECAUSE IT WAS SO HOT. HE GOT A BLISTER FROM IT. THE TREATMENT FOR THE BURN INJURY IS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 12196334 ↗
• MalfunctionMar 24, 2021Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS OVERHEATING AND NON-FUNCTIONAL. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564362 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021, THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, WHEN THE NURSE PASSED THE FIBER THROUGH THE SCOPE, IT WAS BROKEN ABOUT AN INCH FROM THE TIP. BEFORE THE BREAK WAS REALIZED THE LASER WAS INITIALLY FIRED. THERE WERE NO FIBER FRAGMENTS THAT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483357 ↗
• MalfunctionMar 5, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 10, 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT THE LASER UNIT USED WAS A LUMENIS PULSE 100H LASER CONSOLE. IT WAS REPORTED, DURING THE PROCEDURE, THE NURSE UNSCREWED THE LASER FIBER AND IT WAS NOTED TO BE BROKEN AT THE RUBBER OR METAL CONNECTION POINT. THE NURSE GOT A MILD BURN. THE SEVERITY OF THE BURN WAS MINOR/MILD AND WAS TREATED WITH A LOCALIZED TREATMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 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 11420647 ↗
• MalfunctionJan 27, 2021Peeled/Delaminated; Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF FOUR DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-00280 FOR THE FIRST FLEXIVA ID TRACTIP 200 LASER FIBER, MFR. REPORT #3005099803-2021-00285 FOR THE THIRD FLEXIVA ID TRACTIP 200 LASER FIBER AND MFR. REPORT #3005099803-2021-00277 FOR THE FOURTH FLEXIVA ID TRACTIP 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A P100 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED A HIGHER AMOUNT OF FIBER DEGRADATION WAS OCCURRING TO THE POINT WHERE GREEN CLADDING WAS FLAKING OFF. A TOTAL OF FOUR FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED AND THE SAME PROBLEM WAS OBSERVED FOR ALL FOUR FIBERS. THE PROCEDURE WAS COMPLETED WITH A FIFTH FLEXIVA ID TRACTIP 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 11240659 ↗
• MalfunctionJan 27, 2021Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF FOUR DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-00284 FOR THE SECOND FLEXIVA ID TRACTIP 200 LASER FIBER, MFR. REPORT #3005099803-2021-00285 FOR THE THIRD FLEXIVA ID TRACTIP 200 LASER FIBER AND MFR. REPORT #3005099803-2021-00277 FOR THE FOURTH FLEXIVA ID TRACTIP 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 8, 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A P100 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED A HIGHER AMOUNT OF FIBER DEGRADATION WAS OCCURRING TO THE POINT WHERE GREEN CLADDING WAS FLAKING OFF. A TOTAL OF FOUR FLEXIVA ID TRACTIP 200 LASER FIBERS WERE BE USED AND THE SAME PROBLEM WAS OBSERVED FOR ALL FOUR FIBERS. THE PROCEDURE WAS COMPLETED WITH A FIFTH FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11240597 ↗
• MalfunctionJan 27, 2021Peeled/Delaminated; Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO THE FOURTH OF FOUR DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-00280 FOR THE FIRST FLEXIVA ID TRACTIP 200 LASER FIBER, MFR. REPORT #3005099803-2021-00284 FOR THE SECOND FLEXIVA ID TRACTIP 200 LASER FIBER AND MFR. REPORT #3005099803-2021-00285 FOR THE THIRD FLEXIVA ID TRACTIP 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A P100 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED A HIGHER AMOUNT OF FIBER DEGRADATION WAS OCCURRING TO THE POINT WHERE GREEN CLADDING WAS FLAKING OFF. A TOTAL OF FOUR FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED AND THE SAME PROBLEM WAS OBSERVED FOR ALL FOUR FIBERS. THE PROCEDURE WAS COMPLETED WITH A FIFTH FLEXIVA ID TRACTIP 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 11240582 ↗
• MalfunctionJan 27, 2021Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF FOUR DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-00280 FOR THE FIRST FLEXIVA ID TRACTIP 200 LASER FIBER, MFR. REPORT # 3005099803-2021-00284 FOR THE SECOND FLEXIVA ID TRACTIP 200 LASER FIBER AND MFR. REPORT #3005099803-2021-00277 FOR THE FOURTH FLEXIVA ID TRACTIP 200 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 8, 2021 THAT A FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON JANUARY 8, 2021. REPORTEDLY, THE LASER UNIT USED WAS A P100 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED A HIGHER AMOUNT OF FIBER DEGRADATION WAS OCCURRING TO THE POINT WHERE GREEN CLADDING WAS FLAKING OFF. A TOTAL OF FOUR FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED AND THE SAME PROBLEM WAS OBSERVED FOR ALL FOUR FIBERS. THE PROCEDURE WAS COMPLETED WITH A FIFTH FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11240520 ↗
• MalfunctionJan 19, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE FOR A STONE DISEASE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER CONNECTOR GOT EXTREMELY HOT. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FLEXIVA TRACTIP LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11195000 ↗
• MalfunctionJan 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS PERTAINS TO THE SECOND OF TWO FLEXIVA ID TRACTIP 200 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 16, 2020 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE FOR STONES PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STAFF NOTICED IT WAS BROKEN AT THE TIP AREA OF THE FIBER. A SECOND OF THE SAME DEVICE WAS OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11125199 ↗
• MalfunctionJan 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS PERTAINS TO THE FIRST OF TWO FLEXIVA ID TRACTIP 200 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 16, 2020 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE FOR STONES PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STAFF NOTICED IT WAS BROKEN AT THE TIP AREA OF THE FIBER. A SECOND OF THE SAME DEVICE WAS OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11125198 ↗
• InjuryDec 10, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 LASER CONSOLE WITH THE LASER SETTINGS OF 0.2 JOULES AND 50 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE PHYSICIAN REMOVED THE STONES WITH NEPHROSCOPE, HE SWITCHED TO A FLEXIBLE SCOPE. UPON FIRING THE LASER IN THE KIDNEY, THE FIBER BROKE OFF ABOUT 2 INCHES FROM THE TIP. WHEN THE PHYSICIAN PULLED THE SCOPE OUT OF THE PATIENT THE BROKEN PIECE OF FIBER REMAINED IN THE PATIENT. THE PHYSICIAN TRIED TO REMOVE THE BROKEN PIECE OF FIBER WITH A PIRANHA GRASPER, BUT WAS UNSUCCESSFUL. REPORTEDLY, THE INITIAL PCNL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL DEVICE. A FOLLOW UP PROCEDURE WAS DONE TO REMOVE THE BROKEN FIBER. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10988425 ↗
• MalfunctionNov 30, 2020Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 6, 2020 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) . REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT HOLMIUM LASER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TEAM CHANGED THE SETTINGS TO LOW POWER/HIGH FREQUENCY. SUDDENLY, THE LASER CONSOLE SHUT DOWN. WHEN THEY WERE TRYING TO REMOVE THE FIBER, THEY HAD TO USE DOUBLE GLOVES BECAUSE THE CONNECTOR WAS SO HOT. THE FIBER APPEARED TO BE SEPARATED WHERE THE FIBER MEETS THE COLLAR THAT SCREWS INTO THE MACHINE. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 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 10919284 ↗
• MalfunctionNov 12, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOTED TO BE FRAYED. THE ISSUE WAS PRESENT UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 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 10830621 ↗
• MalfunctionOct 6, 2020Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE LASER FIBER DID NOT WORK WHEN PULLED INTO THE LASER CONSOLE. 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 10638229 ↗
• MalfunctionOct 6, 2020Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE LASER FIBER DID NOT WORK WHEN PULLED INTO THE LASER CONSOLE. 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 10638210 ↗
• MalfunctionSep 22, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID TRACTIP 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 P100 WITH THE LASER SETTING OF 8 KILOJOULES. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CONNECTOR OF LASER FIBER WAS NOTED TO BE HOT AND SMELLED LIKE SMOKE INSIDE THE ROOM. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 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 10568190 ↗