Flexiva M0068403920Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08714729808183), received between Jun 15, 2017 and Apr 14, 2022 — classified as 7 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN INSIDE THE DIGITAL FLEXIBLE URETEROSCOPE WHILE LASERING A STONE. THE BROKEN PIECE OF THE LASER FIBER WAS SUCCESSFULLY REMOVED INTACT FROM THE PATIENT. 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 14112448 ↗
• MalfunctionFeb 4, 2022Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA LASER FIBER WAS USED IN A URETEROSCOPY STONE REMOVAL PROCEDURE IN THE DISTAL URETER PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 LASER CONSOLE WITH LASER SETTINGS OF 0.6 JOULES, RATE 50. DURING THE PROCEDURE, AFTER LESS THAN 10 MINUTES, THE LASER BEAM WAS LOST AND THE CONNECTOR OF THE LASER FIBER WAS SUPER HOT TO TOUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT OR USER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457656 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 7, 2021 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS PRESSING HARD ON THE KIDNEY STONE, THE LASER FIBER BROKE INSIDE THE PATIENT'S BODY. THE BROKEN PIECE WAS RETRIEVED WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 12561778 ↗
• MalfunctionApr 8, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIBLE URETEROSCOPY / PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT SETTINGS USED WAS 20 WATTS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE LASER SHAFT HAD SNAPPED IN HALF. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 11637937 ↗
• MalfunctionApr 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A LITHOLAPAXY BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A VERSA PULSE 100 WATT LASER CONSOLE WITH THE LASER SETTINGS OF 1.0 JOULES AND 15 HERTZ. DURING THE PROCEDURE, AFTER FIVE MINUTES OF USE, THE FIBER TIP BROKE OFF. THE PHYSICIAN FLUSHED THE FRAGMENT OUT OF THE PATIENT'S BLADDER WITH A SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 11634487 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 12, 2021 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A URETEROSCOPY (URS) PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER BROKE DURING THE CASE. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 11604184 ↗
• MalfunctionOct 19, 2020Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 25, 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A CYSTOSCOPY - RIGHT RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE LASER FIBER DID NOT WORK WHEN ATTEMPTING TO CONNECT TO THE LASER CONSOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 Consequences Or Impact To Patient

  MAUDE report 10695609 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P100 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573721 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER TIP BROKE OFF INSIDE THE PATIENT. REPORTEDLY, THE DETACHED TIP WAS NOT RETRIEVED. 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 Known Impact Or Consequence To Patient

  MAUDE report 10501917 ↗
• MalfunctionJul 7, 2020Break; Break

  A FLEXIVA 365 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 RETURNED DEVICE WAS ANALYZED AND THE LASER FIBER WAS BROKEN. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242366 ↗
• MalfunctionJun 29, 2020Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 30, 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER FLEXIVA 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 THE LASER FIBER BROKEN WITHIN THE CONNECTOR. 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 10209630 ↗
• MalfunctionJun 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 13, 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS LUMENIS VERSAPULSE 100 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF UPON REMOVAL FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 10118298 ↗
• MalfunctionMar 16, 2020Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A CYSTOSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED AS A HOLMIUM CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN NEAR CONNECTOR AND A SMALL FIRE APPEARED AND THEY WERE ABLE TO PAT THE FIRE OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9834560 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 29, 2020 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN AFTER 20 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 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 9744511 ↗
• MalfunctionOct 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A URETEROSCOPY AND STENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE FIBER BROKE OFF WHEN IT WAS POSITIONED IN THE FIBEROPTIC URETERAL SCOPE. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A ANOTHER FLEXIVA 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9153168 ↗
• MalfunctionJun 3, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. ACCORDING THE COMPLAINANT, DURING PROCEDURE, THE LASER FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 8663096 ↗
• MalfunctionMay 1, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 11 2019 THAT A FLEXIVA 365 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THEY WERE ADVANCING THE LASER FIBER, IT WAS BROKEN 3-4 MM BETWEEN THE SMA CONNECTOR AND THE FIBER BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570007 ↗
• InjuryApr 30, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 365 LASER FIBER WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BURNING SMELL WAS NOTED IN THE OPERATING ROOM. WHEN THE DOCTOR TRIED TO CHANGE THE LASER FIBER, HIS RIGHT THUMB AND INDEX FINGER WERE BURNED UPON SCREWING THE LASER FIBER OFF. THE CONNECTOR OF THE LASER FIBER WAS EXTREMELY HOT TO TOUCH. IT IS UNKNOWN IF ANY TREATMENT WAS ADMINISTER TO TREAT THE PHYSICIAN'S BURN.

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

  MAUDE report 8566204 ↗
• MalfunctionApr 2, 2019Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 365 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS HOLMIUM P100 LASER WITH LASER SETTINGS OF 1 JOULE AND 20 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT GIVING ENOUGH ENERGY TRANSMISSION. THE PHYSICIAN REMOVED THE FIBER AND RECEIVED SECOND DEGREE BURNS ON HIS THUMB AND POINTING FINGER FROM THE CONNECTOR. REPORTEDLY, THE PHYSICIAN WENT TO THE RECOVERY ROOM AND BANDAGED HIS HAND WHICH HAD BLISTERED BUT WERE ALREADY HEALING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

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

  MAUDE report 8475086 ↗
• MalfunctionJan 3, 2019Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 365 LASER FIBER WAS USED DURING A URETEROSCOPY, LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS NO LASER ENERGY COMING OUT FROM THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER. THERE WERE 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 8214766 ↗
• InjuryJan 3, 2019Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT A FLEXIVA 365 LASER FIBER WAS USED FOR AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE AND HURT THE SCRUB NURSE'S HAND. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENT REPORT WILL BE SUBMITTED.

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

  MAUDE report 8213270 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 365 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE LASER FIBER DID NOT WORK UPON PEDAL ACTIVATION AND IT WAS NOTED TO BE BURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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 STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073164 ↗
• InjuryNov 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 365 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE TIP OF THE LASER FIBER BROKE INSIDE THE PATIENT. THE PHYSICIAN PLANS TO RETRIEVE IT DURING SUBSEQUENT SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENT REPORT WILL BE SUBMITTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8064287 ↗
• MalfunctionNov 9, 2018Misfire; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 365 LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 60 WATT CONSOLE WITH LASER SETTINGS OF 0.2 JOULES AND 40 HERTZ. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE CONNECTOR OF THE LASER FIBER WAS NOTED TO SPARKED WHEN IT WAS PLUGGED INTO THE LASER UNIT. REPORTEDLY, THERE WAS NO INJURY TO THE PHYSICIAN/NURSE WHEN THE SPARKED OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8056181 ↗
• MalfunctionNov 5, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 10, 2018 THAT A FLEXIVA 365 LASER FIBER WAS OPENED FOR USE IN A PROCEDURE PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE TIP OF THE LASER FIBER WAS NOTED TO BE CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 365 LASER FIBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8039158 ↗