Flexiva M0068403940Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729808121), received between Feb 17, 2017 and Aug 5, 2021 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (24 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 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 1000 LASER FIBER WAS USED IN A PROCEDURE TO TREAT BLADDER STONES PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER FELL OFF UPON INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281458 ↗
• InjurySep 2, 2020Detachment of Device or Device Component; 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 # 3005099803-2020-03681 FOR THE FIRST FLEXIVA 1000 LASER FIBER AND MFR. REPORT # 3005099803-2020-03682 FOR THE SECOND FLEXIVA 1000 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 1000 LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER TIP BROKE OFF INSIDE THE PATIENT. A SECOND OF THE SAME DEVICE WAS OPENED AND THE SAME ISSUE OCCURRED. REPORTEDLY, THE FIBER TIPS WERE RETRIEVED SUCCESSFULLY WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482984 ↗
• InjurySep 2, 2020Detachment of Device or Device Component; 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 # 3005099803-2020-03681 FOR THE FIRST FLEXIVA 1000 LASER FIBER AND MFR. FOR THE SECOND FLEXIVA 1000 LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 14, 2020 THAT A FLEXIVA 1000 LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER TIP BROKE OFF INSIDE THE PATIENT. A SECOND OF THE SAME DEVICE WAS OPENED AND THE SAME ISSUE OCCURRED. REPORTEDLY, THE FIBER TIPS WERE RETRIEVED SUCCESSFULLY WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482977 ↗
• MalfunctionJul 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2020-02835 FOR THE FIRST FLEXIVA 1000 LASER FIBER AND MFR. REPORT # 3005099803-2020-03056 FOR THE SECOND FLEXIVA 1000 LASER FIBER. A FLEXIVA 1000 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 TIP WAS DETACHED. IT WAS CONFIRMED ON JULY 21, 2020 THAT THIS WAS DEVICE WAS USED IN A PROCEDURE ON (B)(6) 2020. THE FLEXIVA 1000 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 LUMENIS 20 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE. A SECOND OF THE SAME DEVICE WAS OPENED AND FAILED. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA 1000 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 TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10346120 ↗
• MalfunctionJul 22, 2020Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 2, 2020 THAT A FLEXIVA 1000 LASER FIBER USED IN A CYSTOSCOPY LASER FRAGMENTATION AND EVACUATION BLADDER PROCEDURE FOR A STONE IN THE BLADDER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT WORKING/NOT FIRING. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA ID 550 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 Consequences Or Impact To Patient

  MAUDE report 10310955 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 1000 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 LUMENIS 20 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285560 ↗
• MalfunctionApr 8, 2020Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 13, 2020 THAT A FLEXIVA 1000 LASER FIBER WAS USED IN A CYSTO LASER LITHO PROCEDURE IN THE URETER PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO ENERGY COMING OUT FROM THE LASER FIBER AND THE LASER FIBER WAS NOT FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 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 TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938809 ↗
• MalfunctionOct 1, 2019Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 1000 LASER FIBER USED IN A BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE WITH HIGH HERTZ SETTINGS ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO ENERGY COMING OUT FROM THE 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 TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142663 ↗
• MalfunctionSep 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 7, 2019 THAT A FLEXIVA 1000 LASER FIBER USED IN A BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100W CONSOLE WITH HIGH HERTZ SETTINGS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE LASER FIBER WAS MISSING UPON OPENING THE PACKAGE. 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 8966639 ↗
• MalfunctionJul 8, 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 1000 LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. FLUSHING WAS DONE ON THE DETACHED TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768842 ↗
• InjuryMay 2, 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 1000 LASER FIBER WAS USED DURING A REMOVAL OF BLADDER STONES PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. REPORTEDLY, THE FIBER TIP WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 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 8574270 ↗
• MalfunctionApr 23, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 1000 LASER FIBER WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. 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 Consequences Or Impact To Patient

  MAUDE report 8539624 ↗
• MalfunctionMar 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 13, 2019 THAT A FLEXIVA 1000 LASER FIBER WAS USED IN A LITHOLAPAXY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE UPON TAKING THE FIBER OUT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER THERE WAS NO SERIOUS INJURY NOR WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409533 ↗
• MalfunctionNov 26, 2018Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 1000 LASER FIBER WAS USED DURING A BLADDER STONE REMOVAL PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 WATT CONSOLE WITH LASER SETTINGS OF 0.5 JOULES AND 80 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE LASER FIBER BURNED OFF AFTER TEN SECONDS OF USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 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 FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102479 ↗
• MalfunctionSep 4, 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 1000 LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE FIBER TIP DETACHED AFTER TWO MINUTES OF USE. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC 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 7842880 ↗
• InjuryJul 23, 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 1000 LASER FIBER WAS USED DURING A CYSTOSCOPY LITHOLAPAXY PROCEDURE IN THE URETHRA PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS 100 WATT HOLMIUM WITH LASER SETTINGS OF 1.0 JOULES AND A RATE 15. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT¿S URETHRA. THE BROKEN FRAGMENT WAS RETRIEVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 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 "PATIENT IS UNAFFECTED BY EVENT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7711247 ↗
• MalfunctionJul 20, 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 1000 LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT WAS A LUMENIS 60W. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT¿S BLADDER WHILE LASERING. IT WAS UNKNOWN IF THE BROKEN FRAGMENT WAS RETRIEVED INSIDE THE PATIENT'S BLADDER. 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. 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 Consequences Or Impact To Patient

  MAUDE report 7706765 ↗
• InjuryJul 12, 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 1000 LASER FIBER WAS USED DURING A CYSTOLITHOTOMY WITH LASER LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT¿S BLADDER. THE BROKEN FRAGMENT WAS RETRIEVED USING A FORCEP. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 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 7683308 ↗
• MalfunctionJun 5, 2018Material Deformation; Material Deformation

  A FLEXIVA 1000 LASER FIBER WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 AND EXAMINED ON (B)(6) 2018. ACCORDING TO INITIAL INSPECTION OF THE RETURNED LASER FIBER, THE FIBER TIP WAS DAMAGED. 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 7569347 ↗
• MalfunctionMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS MANUFACTURER REPORT PERTAINS TO THE ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01669, 3005099803-2018-01670 AND 3005099803-2018-01671 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE FLEXIVA 1000 LASER FIBERS WERE USED IN A CYSTOSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS VERSAPULSE 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST FIBER WAS USED FOR 10 MINUTES AND THE TIP BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01669). ANOTHER FIBER WAS USED AND AFTER 5 MINUTES, THE TIP ALSO BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01670). A THIRD FIBER WAS THEN USED AND AFTER 2 MINUTES, THE TIP ALSO BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01671). REPORTEDLY, THE FIBER FRAGMENTS THAT FELL INSIDE THE PATIENT WERE FLUSHED OUT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553947 ↗
• MalfunctionMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS MANUFACTURER REPORT PERTAINS TO THE ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01669, 3005099803-2018-01670 AND 3005099803-2018-01671 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE FLEXIVA 1000 LASER FIBERS WERE USED IN A CYSTOSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS VERSAPULSE 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST FIBER WAS USED FOR 10 MINUTES AND THE TIP BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01669). ANOTHER FIBER WAS USED AND AFTER 5 MINUTES, THE TIP ALSO BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01670). A THIRD FIBER WAS THEN USED AND AFTER 2 MINUTES, THE TIP ALSO BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01671). REPORTEDLY, THE FIBER FRAGMENTS THAT FELL INSIDE THE PATIENT WERE FLUSHED OUT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553939 ↗
• MalfunctionMay 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS: 3005099803-2018-01669, 3005099803-2018-01670 AND 3005099803-2018-01671 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE FLEXIVA 1000 LASER FIBERS WERE USED IN A CYSTOSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS VERSAPULSE 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST FIBER WAS USED FOR 10 MINUTES AND THE TIP BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01669). ANOTHER FIBER WAS USED AND AFTER 5 MINUTES, THE TIP ALSO BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01670). A THIRD FIBER WAS THEN USED AND AFTER 2 MINUTES, THE TIP ALSO BROKE OFF (CAPTURED IN MFR. REPORT NUMBER 3005099803-2018-01671). REPORTEDLY, THE FIBER FRAGMENTS THAT FELL INSIDE THE PATIENT WERE FLUSHED OUT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553937 ↗
• MalfunctionApr 24, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 1000 LASER FIBER WAS OPENED FOR USE IN A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE LASER FIBER WAS NOTED TO BE BROKEN IN HALF UPON REMOVAL FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 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 7453838 ↗
• MalfunctionApr 5, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 1000 LASER FIBER WAS OPENED FOR USE IN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING AND OUTSIDE THE PATIENT, THE LASER FIBER BROKE UPON REMOVAL FROM THE SEALED PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. 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 7399716 ↗
• MalfunctionDec 7, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A FLEXIVA 1000 LASER FIBER WAS USED DURING A BLADDER STONE LITHOLAPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LASER UNIT USED WAS HOLMIUM 100 WATT LASER CONSOLE WITH SETTINGS OF 1 JOULE AND 50 HERRTZ. THE TOTAL ENERGY USED WAS 50 WATTS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN HIT THE PEDAL TO FIRE LASER ENERGY AT THE STONE, THE FIBER TIP BROKE OFF. THERE WERE NO FIBER FRAGMENTS OBSERVED INSIDE THE PATIENT AND NOTHING WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 7097446 ↗