Flexiva™ ID M006R8403910Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 08714729963752), received between Mar 1, 2018 and May 19, 2022 — classified as 6 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Break” (101 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 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2022Break; Break

  A FLEXIVA ID 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 DEVICE WAS ANALYZED AND THE INVESTIGATION RESULTS REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435755 ↗
• MalfunctionMay 12, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT FLEXIVA ID 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 14377788 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 18, 2022 THAT FLEXIVA ID 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 AND FIBER BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377775 ↗
• MalfunctionApr 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA ID HIGH POWER SINGLE USE LASER FIBER WAS USED IN A URETEROSCOPY TO TREAT A STONE IN THE URETER PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A MOSES 1.0 LASER CONSOLE. DURING INSERTION, THE LASER FIBER WAS SEEN TO CLEAVE THROUGH LITHOVUE SCOPE PRIOR TO USE. THE TIP OF THE LASER FIBER WAS BROKEN. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187750 ↗
• MalfunctionApr 20, 2022Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA ID HIGH POWER SINGLE USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE TO TREAT A STONE IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A MOSES LASER CONSOLE WITH THE LASER SETTINGS OF 0.2 JOULES AND 50 HERTZ. DURING PROCEDURE, THE LASER FIBER STOPPED WORKING. WHEN THE PHYSICIAN WENT TO UNPLUG, THE FIBER CONNECTOR WAS VERY HOT TO TOUCH. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162152 ↗
• MalfunctionDec 27, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021 . THE LASER UNIT USED WAS A MOSES P120 LASER CONSOLE. DURING THE PROCEDURE, THERE WAS CRACKLED SOUND HEARD FROM THE LASER FIBER CONNECTOR AND IT BECAME HOT. THERE WAS NO BURN INJURY TO THE OPERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 13087533 ↗
• MalfunctionNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 26, 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS TO BE USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER TIP WAS NOTED BROKEN UPON OPENING THE PACKAGE. 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 12819863 ↗
• MalfunctionSep 3, 2021Break; Optical Problem; Break; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 22, 2021 THAT A FLEXIVA 200 LASER FIBER WAS USED IN A PROCEDURE IN THE URETER PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER DID NOT HAVE A PILOT LIGHT. 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 BROKEN WITHIN THE CONNECTOR.

  Patient problems: Insufficient Information

  MAUDE report 12421535 ↗
• MalfunctionJul 8, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 17, 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS INSPECTED FOR A PROCEDURE IN THE KIDNEY ON AN UNKNOWN DATE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THERE WAS A HAIR INSIDE THE PRODUCT PACKAGE. THE HAIR WAS VISIBLE FROM THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 12134582 ↗
• MalfunctionJun 30, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER DID NOT WORK AND A LASER ERROR CAME UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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. 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 12094663 ↗
• MalfunctionJun 23, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN URETEROSCOPY PROCEDURE IN THE LOWER POLE OF KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 120 WATT LASER CONSOLE WITHLASER SETTINGS OF 0.8 JOULES AND 8 HERTZ. DURING THE PROCEDURE, THE LASER FIBER WAS WORKING FOR FIVE MINUTES AND SUDDENLY STOPPED FIRING IN THE MIDDLE OF THE CASE. THE ENERGY FROM THE LASER TO THE FIBER WAS STILL OCCURRING, BUT NOTHING WAS TRANSMITTING FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 200 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12049325 ↗
• MalfunctionMay 13, 2021Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A MOSES CONSOLE. DURING PROCEDURE, THE LASER FIBER DID NOT WORK ONCE PLUGGED IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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. 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 11816305 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 19, 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY FOR KIDNEY STONES PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A MOSES LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 200 LASER FIBER. THERE WERE PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787093 ↗
• MalfunctionApr 22, 2021Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-01884 FOR THE FIRST FLEXIVA ID 200 LASER FIBER AND MFR. REPORT FOR THE SECOND FLEXIVA ID 200 LASER FIBER LASER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 1, 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 30H LASER CONSOLE. DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL, THERE WAS NO ENERGY COMING OUT FROM THE LASER FIBER. THE AIMING BEAM DID NOT SHOW AND A BURNING SMELL WAS NOTICED. ADDITIONALLY, THE FIBER CONNECTOR FELT WARM. ANOTHER FLEXIVA ID 200 LASER FIBER WAS OPENED AND THE SAME EXACT ISSUE OCCURRED. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA ID 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 11708094 ↗
• MalfunctionApr 22, 2021Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-01884 FOR THE FIRST FLEXIVA ID 200 LASER FIBER AND MFR. REPORT #3005099803-2021-01885 FOR THE SECOND FLEXIVA ID 200 LASER FIBER LASER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6), 2021. THE LASER UNIT USED WAS A LUMENIS 30H LASER CONSOLE. DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL, THERE WAS NO ENERGY COMING OUT FROM THE LASER FIBER. THE AIMING BEAM DID NOT SHOW AND A BURNING SMELL WAS NOTICED. ADDITIONALLY, THE FIBER CONNECTOR FELT WARM. ANOTHER FLEXIVA ID 200 LASER FIBER WAS OPENED AND THE SAME EXACT ISSUE OCCURRED. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA ID 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 11708087 ↗
• MalfunctionApr 8, 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 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 LASER CONSOLE WITH LASER SETTINGS 0.5 JOULES AND 80HERTZ. DURING THE PROCEDURE, THE LASER WAS CONNECTED AND RECOGNIZED BY THE LASER CONSOLE, BUT UPON PRESSING DOWN THE FOOT PEDAL THE LASER FIBER CONNECTOR MADE A CRACKLING SOUND AND DID NOT FIRE LASER ENERGY TO THE STONE. THE CONNECTOR WAS HOT TO TOUCH, BUT NO VISIBLE DAMAGE WAS NOTED TO THE CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 200 LASER FIBER. THERE WAS NO ADVERSE EVENT OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634478 ↗
• MalfunctionMar 9, 2021Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 WATT LASER CONSOLE. DURING THE PROCEDURE, THE BASE OF THE FIBER NEAR THE CONSOLE WAS NOTED TO BE OVERHEATING. DURING THE PROCESS OF FIRING THE FIBER THE RUBBER PIECE THAT IS CONNECTING THE FIBER TO THE SCREW ON PORTION BROKE OFF THE BASE OF THE FIBER. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 11444622 ↗
• MalfunctionMar 1, 2021Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 6, 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED, DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL, THERE WAS NO ENERGY COMING OUT FROM THE LASER FIBER. NO ERROR CODE WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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. 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 11396273 ↗
• MalfunctionFeb 10, 2021Melted; Overheating of Device; Melted; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER CONNECTOR MELTED AT THE GREEN HUB PORTION AND RUBBER OF THE FIBER BODY. ONCE THE PHYSICIAN NOTICED A BURNING SMELL, USAGE WAS STOPPED AND THE LASER FIBER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 11307471 ↗
• MalfunctionDec 23, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY, URETER AND BLADDER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A MOSES LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 11065677 ↗
• InjuryNov 24, 2020Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 2, 2020 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY AND URETER PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 HOLMIUM LASER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE LASER FIBER FROM THE SCOPE, BUT HE NOTICED THAT THE LASER FIBER WAS NOT COMING OUT. THE PHYSICIAN CONTINUED TO REMOVE THE FIBER AND NOTICED A PIECE OF THE FIBER HAD BROKEN OFF. THE FIBER BROKE APPROXIMATELY 6 CM BACK FROM THE TIP OF THE FIBER. REPORTEDLY, IT WAS NOTICED AFTER THE CASE THAT THE SCOPE WAS BURNED. THE PHYSICIAN SUCCESSFULLY USED A BASKET TO RETRIEVE THE LASER FIBER FRAGMENT THAT FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 EFFORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10898056 ↗
• MalfunctionNov 16, 2020Break; Overheating of Device; Material Deformation; Break; Overheating of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 23, 2020 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN CYSTOSCOPY URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT PLACEMENT PROCEDURE IN THE KIDNEY PERFORMED ON(B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS LUMENIS LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER SUDDENLY STOPPED WORKING. THE STAFF REMOVED THE END OF THE FIBER AND IT WAS NOTED TO SMELL LIKE SMOKE AND BURNT METAL. ADDITIONALLY, THE "LENS AT THE END OF THE FIBER HAD 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 Known Impact Or Consequence To Patient

  MAUDE report 10846991 ↗
• MalfunctionNov 5, 2020Melted; Overheating of Device; Melted; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 15, 2020 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE LASER FIBER WAS NOT WORKING CORRECTLY. THE BLACK CONNECTOR APPEARED TO BE SEPARATED FROM THE GREEN CONNECTOR. THE CONNECTOR ALSO FELT WARM AND APPEARED TO BE MELTED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 10795452 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON AN UNKNOWN DATE. STONE. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P100 LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE FIBER CRACKED". THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 Consequences Or Impact To Patient

  MAUDE report 10791292 ↗
• MalfunctionOct 14, 2020Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020, THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN AN URETEROSCOPY PROCEDURE IN THE KIDNEY FOR THE STONE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 50 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER 5 MINUTES THE LASER FIBER TIP WORE DOWN VERY QUICKLY AND THE SHEATH STARTED TO FRAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 10678431 ↗