Flexiva™ ID M006R8403920Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729963776), received between Mar 21, 2018 and Feb 24, 2022 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2022Break; Misfire; Material Integrity Problem; Break; Misfire; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA LASER FIBER WAS USED IN THE KIDNEY FOR A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER BROKE AND BURNED A HOLE THROUGH THE CHANNEL OF THE SCOPE. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THERE WAS NO BURN INJURY TO THE OPERATOR OR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595403 ↗
• MalfunctionOct 7, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A LASER LITHOTRIPSY 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 HAS MALFUNCTIONED, AND REPEATEDLY GAVE AN ERROR MESSAGE THAT THE LASER FIBER NEEDS TO BE ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 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. 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 12594915 ↗
• MalfunctionOct 7, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING PREPARATION, THE LASER FIBER DID NOT TURN ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 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. 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 12594880 ↗
• MalfunctionSep 1, 2021Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 9, 2021 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THE FIBER CONNECTOR WAS NOTED TO BE HOT. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12409710 ↗
• MalfunctionFeb 17, 2021Degraded; Fracture; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY AND URETER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 10 WATT LASER CONSOLE WITH THE LASER SETTING 0.8 X 8 JOULES AND 0.3 X 53 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER TIP WAS DEGRADING ABNORMALLY FAST AND SEEMED TO SPARK ON THE INCREDIBLY HARD STONE. THE AIMING BEAM WAS ALSO VISIBLE ALONG THE OUTSIDE JACKET OF THE ENTIRE LENGTH OF THE FIBER SEVERAL TIMES DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 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 LASER FIBER TIP/FACE DEFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337501 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6)2020 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A LITHOTRIPSY WITH HOLMIUM LASER PROCEDURE IN THE KIDNEY PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE AT THE CONNECTION TO THE LASER CONSOLE AFTER LASER ACTIVATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10713188 ↗
• MalfunctionMar 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID 365 LASER FIBER WAS OPENED FOR USE FOR A GREENLIGHT CYSTOSCOPY PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THERE WAS A HAIR INSIDE THE PACKAGE WHEN IT WAS INSPECTED. THE PACKAGE WAS NOT OPENED, BUT THE HAIR WAS VISIBLE FROM THE OUTSIDE. THERE WAS NO VISIBLE DAMAGE ON THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884989 ↗
• MalfunctionMar 4, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SEVENTH OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788583 ↗
• MalfunctionNov 5, 2019Melted; Overheating of Device; Melted; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 16, 2019 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED IN (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT WORKING PROPERLY AND THE JUNCTION ATTACHMENT WAS MELTED BY THE LASER GENERATOR. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281329 ↗
• MalfunctionAug 26, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION JULY 2, 2019 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AIMING BEAM WAS NOTED TO BE GLOWING THROUGH THE SHAFT OF THE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932016 ↗
• MalfunctionAug 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 24, 2019 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE AFTER 20 MINUTES OF USE. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TYPE OF LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893879 ↗
• MalfunctionApr 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO FLEXIVA ID 365 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO FLEXIVA ID 365 LASER FIBERS WERE USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 30 WATT LASER CONSOLE WITH LASER SETTINGS OF 0.6 JOULES AND 6 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER WAS BROKEN AFTER A FEW LASER ACTIVATIONS. A SECOND OF THE SAME DEVICE WAS OPENED AND IT WAS NOTED TO BE BROKEN ABOUT 12 INCHES FROM THE TIP OUTSIDE THE PATIENT AFTER INTRODUCTION INTO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE THIRD FLEXIVA ID 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519602 ↗
• MalfunctionApr 16, 2019Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO FLEXIVA ID 365 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO FLEXIVA ID 365 LASER FIBERS WERE USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 30 WATT LASER CONSOLE WITH LASER SETTINGS OF 0.6 JOULES AND 6 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER WAS BROKEN AFTER A FEW LASER ACTIVATIONS. A SECOND OF THE SAME DEVICE WAS OPENED AND IT WAS NOTED TO BE BROKEN ABOUT 12 INCHES FROM THE TIP OUTSIDE THE PATIENT AFTER INTRODUCTION INTO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE THIRD FLEXIVA ID 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519599 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO FLEXIVA ID 365 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO FLEXIVA ID 365 LASER FIBERS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS LUMENIS 30 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UPON STARTING TO LASER THE STONE, THE TIP OF THE LASER FIBER FLEW OFF. THEY TRIED A SECOND FIBER AND THE SAME THING HAPPENED. PER THE SURGEON, THE FIBER TIPS WERE FLUSHED OUT WITH THE PROCEDURAL IRRIGATION. THE PROCEDURE WAS COMPLETED WITH THE SECOND FIBER, HOWEVER, IT WAS NOTED THAT THE PERFORMANCE WAS NOT OPTIMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8297403 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO FLEXIVA ID 365 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 8, 2019 THAT A FLEXIVA ID 365 LASER FIBER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS LUMENIS 30 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UPON STARTING TO LASER THE STONE, THE TIP OF THE LASER FIBER FLEW OFF. THEY TRIED A SECOND FIBER AND THE SAME THING HAPPENED. PER THE SURGEON, THE FIBER TIPS WERE FLUSHED OUT WITH THE PROCEDURAL IRRIGATION. THE PROCEDURE WAS COMPLETED WITH THE SECOND FIBER, HOWEVER, IT WAS NOTED THAT THE PERFORMANCE WAS NOT OPTIMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8297402 ↗
• InjuryJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 3, 2019 THAT A FLEXIVA ID 365 LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE IN THE BLADDER AND URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM PULSE WITH LASER SETTINGS OF 21 WATTS, 0.3 JOULES AND PULSE FREQUENCY OF 70 HERTZ AND 0.72 KILOJOULES. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE LASER FIBER TIP WAS DETACHED INSIDE THE PATIENT WHILE BLASTING THE RENAL STONE. THE FIBER TIP WAS RETRIEVED SUCCESSFULLY. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273919 ↗
• MalfunctionJan 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 2, 2019 THAT A FLEXIVA ID 365 LASER FIBER WAS USED FOR A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP FLEW OFF THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 ID LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270450 ↗
• MalfunctionJan 15, 2019Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY THE LASER UNIT USED WAS A MOSES P120 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS NOT EMITTING ENOUGH LASER ENERGY TO BREAK THE CALCULI. THE STAFF CHECKED THE FIBER AND FOUND THAT THE FIBER CONNECTOR WAS HOT TO TOUCH. REPORTEDLY, THE STAFF WAS NOT BURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246900 ↗
• MalfunctionNov 27, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 365 LASER FIBER WAS OPENED FOR USE IN A CYSTOSCOPY URETERAL STONE EXTRACTION WITH LASER PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER WAS NOTED TO BE BROKEN AND APPROXIMATELY 2 INCHES WAS STUCK IN THE URETEROSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCOPE AND FLEXIVA ID 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8107926 ↗
• InjuryNov 12, 2018Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 18, 2018 THAT A FLEXIVA ID 365 LASER FIBER WAS OPENED FOR USE FOR A STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS MOSES PULSE 120H CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOTICED TO BE BROKEN. ADDITIONALLY, THE FIBER CONNECTION WAS HOT AND THE NURSE'S FINGERS WERE BURNED THROUGH HER GLOVES WHEN SHE DISCONNECTED THE FIBER. IT IS UNKNOWN WHETHER ANY TREATMENT WAS DONE TO THE BURNED AREA. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA ID 550 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: Burn(s); No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8062532 ↗
• MalfunctionOct 16, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 365 LASER FIBER WAS OPENED FOR USE FOR A UTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE LASER FIBER WAS NOTED TO BE BROKEN WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968655 ↗
• InjuryOct 12, 2018Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE FLEXIVA LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 14, 2018 THAT THREE FLEXIVA LASER FIBERS [FLEXIVA ID 365, FLEXIVA ID TRACTIP 200 AND FLEXIVA ID 200] WERE USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE RIGHT KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT A FLEXIVA ID TRACTIP 200 LASER FIBER AND A FLEXIVA ID 200 LASER FIBER WERE BROKEN BEFORE IT WAS USE ON THE PATIENT. A FLEXIVA ID 365 WAS USED AND IT WAS BROKEN INSIDE THE LITHOVUE DISPOSABLE URETEROSCOPE. A BROKEN FRAGMENT FELL INSIDE THE KIDNEY. A NEW FLEXIBLE LITHOVUE URETEROSCOPE WAS OPENED AND THE BROKEN PIECE WAS RETRIEVED BY BASKET EXTRACTION FROM THE RIGHT KIDNEY. THE PROCEDURE WAS COMPLETED. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7961301 ↗
• MalfunctionOct 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 365 LASER FIBER WAS OPENED FOR USE IN URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE THE PATIENT, THE LASER FIBER WAS NOTED TO BE BROKEN IN HALF UPON REMOVAL FROM COIL IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7959917 ↗
• MalfunctionOct 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 365 LASER FIBER WAS OPENED FOR USE IN URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE THE PATIENT, THE LASER FIBER WAS NOTED TO BE BROKEN IN HALF UPON REMOVAL FROM COIL IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7959914 ↗
• MalfunctionSep 25, 2018Break; Detachment of Device or Device Component

  DURING URETEROSCOPY WITH LASER LITHOTRIPSY, HOLMIUM LASER FIBERS X3 BROKE DURING SURGERY. FLEXIVA ID TRAC TIP 200 FIBER X2 (LOTS # 0000006252 AND 6261) BROKE PRIOR TO USE ON PATIENT. THESE WERE NOT USED. FLEXIVA ID 365 FIBER (LOT # 0000006265) BROKE IN THE LITHOVUE DISPOSABLE URETEROSCOPE AND A PIECE OF THE FIBER WENT INTO THE RIGHT KIDNEY. A NEW FLEXIBLE LITHOVUE URETEROSCOPE WAS OPENED AND THE PIECE WAS RETRIEVED BY BASKET EXTRACTION FROM THE RIGHT KIDNEY. ALL FIBERS WERE KEPT AS WELL AS THE RETRIEVED PIECE OF FIBER FROM THE KIDNEY. THERE WAS ALSO ANOTHER FLEXIVA PACKAGE IN WHICH THE WIRE WAS POPPED OUT OF THE PACKAGE BEFORE IT WAS OPENED, LOT # 0000006205. PROCEDURAL NOTE: "THE STRICTURE DILATED WELL. THE WIRE WAS EXCHANGED FOR AN AMPLATZ SUPERSTIFF WIRE AND THE LITHOBID URETEROSCOPE WAS PLACED. IT PASSED EASILY THROUGH THE STRICTURE UP INTO THE LEVEL OF THE KIDNEY. THE KIDNEY WAS VERY HYDRONEPHROTIC. A 365M HOLMIUM LASER FIBER WAS USED TO FRAGMENT THE MULTIPLE STONES THAT WERE SEEN IN THE VERY SMALL PIECES. AT ONE POINT THE FIBER DID BREAK AND ACTUALLY A PIECE OF FIBER BROKE OFF. FORTUNATELY, I WAS ABLE TO USE A 0 TIP BASKET AND RETRIEVE IT AND REMOVE IT IN ITS ENTIRETY." "THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905068 ↗