Flexiva M0068403930Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729808206), received between Feb 20, 2018 and Jun 23, 2021 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A CYSTOLITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN INSIDE THE SCOPE. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO UNRELATED REASONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049357 ↗
• InjuryOct 30, 2020Melted; Overheating of Device; Detachment of Device or Device Component; Melted; Overheating of Device; Detachment of Device or Device Component

  THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2020-04984 FOR THE FLEXIVA LASER FIBER, MFR REPORT #3005099803-2020-04985 FOR THE FLEXIVA LASER FIBER AND MFR REPORT #3005099803-2020-04986 FOR THE FLEXIVA LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS BEGINNING TO MELT INSIDE THE PATIENT. A SECOND AND THIRD OF THE SAME DEVICE WAS USED AND THE SAME ISSUE OCCURRED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. DUE TO THE LASER FIBER FAILURE THE PROCEDURE WAS COMPLETED VIA OPEN SURGERY, OPEN PROSTATECTOMY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10762997 ↗
• InjuryOct 30, 2020Melted; Overheating of Device; Detachment of Device or Device Component; Melted; Overheating of Device; Detachment of Device or Device Component

  THIS REPORT PERTAINS TO THE SECOND OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2020-04984 FOR THE FLEXIVA LASER FIBER, MFR REPORT #3005099803-2020-04985 FOR THE FLEXIVA LASER FIBER AND MFR REPORT #3005099803-2020-04986 FOR THE FLEXIVA LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6 2020 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS BEGINNING TO MELT INSIDE THE PATIENT. A SECOND OF THE SAME DEVICE WAS USED AND THE SAME ISSUE OCCURRED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. DUE TO THE LASER FIBER FAILURE THE PROCEDURE WAS COMPLETED VIA OPEN SURGERY, OPEN PROSTATECTOMY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10762940 ↗
• InjuryOct 30, 2020Melted; Overheating of Device; Detachment of Device or Device Component; Melted; Overheating of Device; 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 #3005099803-2020-04984 FOR THE FLEXIVA LASER FIBER, MFR REPORT #3005099803-2020-04985 FOR THE FLEXIVA LASER FIBER AND MFR REPORT #3005099803-2020-04986 FOR THE FLEXIVA LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS BEGINNING TO MELT INSIDE THE PATIENT. A SECOND AND THIRD OF THE SAME DEVICE WAS USED AND THE SAME ISSUE OCCURRED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. DUE TO THE LASER FIBER FAILURE THE PROCEDURE WAS COMPLETED VIA OPEN SURGERY, OPEN PROSTATECTOMY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10762936 ↗
• MalfunctionMar 2, 2020Misfire; Material Integrity Problem; Misfire; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 5, 2020 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A TRANSURETHERAL PROSTATE ENUCLEATION IN THE PROSTATE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UPON PRESSING DOWN THE FOOT PEDAL, AN ABNORMAL SOUND WAS HEARD. THE BLAST SHIELD WAS NOTED TO BE BURNT AND THE FIBER WAS ALSO DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 LASER FIBER. 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 9773912 ↗
• MalfunctionFeb 25, 2020Detachment of Device or Device Component; Optical Problem; Detachment of Device or Device Component; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 6, 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A LASER STONE CASE PROCEDURE PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AIMING BEAM WAS UNDETECTABLE AND THE TIP OF THE LASER FIBER WAS NOTED TO BE MISSING. THE TIP WAS UNDETECTABLE UNDER XRAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752046 ↗
• MalfunctionJan 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6), 2020 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A HOLEP PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6), 2020. REPORTEDLY, THE LASER UNIT WAS A LUMENIS VP 100W CONSOLE WITH SETTINGS OF 30 HZ AND 1.5 J. ACCORDING TO THE COMPLAINANT, THE GLASS TIP BROKE OFF INSIDE THE PATIENT BETWEEN LOBES OF THE PROSTATIC TISSUE. THE BLADDER WAS MORCELLATED AND THOROUGHLY WASHED OUT AND THE BLADDER, PROSTATIC FOSSA AND URETHRA WAS FULLY ASSESSED AT THE END OF THE PROCEDURE TO ENSURE THAT NO FRAGMENTS WERE REMAINING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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: No Consequences Or Impact To Patient

  MAUDE report 9648862 ↗
• MalfunctionJun 12, 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 550 LASER FIBER USED IN A CYSTOSCOPY WITH CYSTOLITHOLAPAXY 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. THE PROCEDURE WAS NOT COMPLETED AND IT WAS RESCHEDULED. IT WAS UNKNOWN IF THE DETACHED TIP WAS RETRIEVED INSIDE THE BLADDER. 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 WAS CONDITION WAS FINE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691826 ↗
• MalfunctionApr 18, 2019Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPE STONE BREAKING PROCEDURE IN THE KIDNEY ON (B)(6) 2019. ACCORDING THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTED THAT THERE WAS NOT ENOUGH POWER FOR LASER ACTIVATION WITH VARIOUS SETTINGS THAT WERE APPLIED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 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 TIP WAS CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527933 ↗
• MalfunctionApr 18, 2019Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPE STONE BREAKING PROCEDURE IN THE KIDNEY ON (B)(6) 2019. ACCORDING THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTED THAT THERE WAS NOT ENOUGH POWER FOR LASER ACTIVATION WITH VARIOUS SETTINGS THAT WERE APPLIED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 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 TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527480 ↗
• MalfunctionMar 20, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 550 LASER FIBER WAS OPENED FOR USE FOR A FLEXIBLE URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER WAS NOTED TO BE BROKEN RIGHT OUT OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8437177 ↗
• MalfunctionNov 12, 2018Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS ONE OF FOUR FLEXIVA LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE MIDDLE PART OF THE LASER FIBER WAS BROKEN OUTSIDE THE PATIENT. THREE MORE FLEXIVA LASER FIBERS WERE USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FIFTH FLEXIVA LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS 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 8059923 ↗
• MalfunctionNov 12, 2018Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS ONE OF FOUR FLEXIVA LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE MIDDLE PART OF THE LASER FIBER WAS BROKEN OUTSIDE THE PATIENT. THREE MORE FLEXIVA LASER FIBERS WERE USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FIFTH FLEXIVA LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS 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 8059822 ↗
• MalfunctionJul 3, 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 550 LASER FIBER WAS USED DURING A BLADDER STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE FIBER TIP BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 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 7658424 ↗
• MalfunctionJun 6, 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 550 LASER FIBER WAS OPENED FOR USE IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT DURING PREPARATION AND OUTSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT THE TIP OF LASER FIBER WAS BROKEN UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 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 7574880 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A BLADDER STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER BROKE. THERE WERE NO REPORTED FIBER FRAGMENTS THAT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 LASER FIBER. 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 7551051 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 7, 2018 THAT A FLEXIVA 550 LASER FIBER WAS OPENED FOR USE IN A RIRS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING AND OUTSIDE THE PATIENT, THE LASER FIBER WAS FOUND DEFECTIVE AND BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 7551024 ↗
• MalfunctionMay 17, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 29, 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS DORNIER 21 CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THE LASER FIBER DEGRADES QUICKER THAN NORMAL USE AND A POPPING AND CLICKING SOUND WAS HEARD FROM THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 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. 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 7523686 ↗
• MalfunctionApr 11, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018 ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, AFTER THE LASER FIBER WAS CONNECTED INTO THE LASER CONSOLE, THE AIMING BEAM WAS NOT VISIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 550 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421145 ↗
• MalfunctionMar 21, 2018Material Integrity Problem; Material Integrity Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT 3005099803-2018-00281 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT TWO FLEXIVA 550 LASER FIBERS WERE USED IN A PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE AND IT WAS UNKNOWN IF THE LASER CONSOLE HAS BEEN RFID MODIFIED TO BE USED WITH FLEXIVA LASER FIBERS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE LASER FIBER STOPPED FIRING ENERGY AFTER 10 TO 15 MINUTES OF USE. A SECOND FLEXIVA 550 LASER FIBER WAS USED AND THE SAME THING HAPPENED. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THERE WERE DEBRIS ON THE FIBER FACE WITHIN THE SMA CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357622 ↗
• MalfunctionFeb 28, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 550 LASER FIBER WAS USED DURING A TRANSURETHRAL RESECTION OF THE PROSTRATE (TURP) PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, A FUNNY SMELL WAS NOTED WHEN THEY STARTED THE PROCEDURE AND THEY FELT THAT THERE WAS AN ISSUE WITH THE FIBER. THEY REMOVED THE LASER FIBER AND COMPLETED THE PROCEDURE WITH ANOTHER FLEXIVA 550 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. 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 AND TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302689 ↗
• MalfunctionFeb 20, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A FLEXIVA 550 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE AND IT WAS UNKNOWN IF THE LASER CONSOLE HAS BEEN RFID MODIFIED TO BE USED WITH FLEXIVA LASER FIBERS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE LASER FIBER STOPPED FIRING ENERGY AFTER 10 TO 15 MINUTES OF USE. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THERE WERE DEBRIS ON THE FIBER FACE WITHIN THE SMA CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281978 ↗