Flexiva M0068403910Recalls & reported problems

Summary

The FDA's MAUDE database contains 376 adverse event reports that list this exact device (DI 08714729808145), received between Jan 4, 2017 and Jun 8, 2023 — classified as 10 injuries, 366 malfunctions.

The most frequently reported specific device problem is “Break” (292 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 376 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER HAD AN ENERGY TRANSMISSION ISSUE DURING PROCEDURE. ANOTHER FIBER WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE FIBER WAS RETURNED, AND ANALYSIS IDENTIFIED A FIBER CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17094223 ↗
• MalfunctionJan 23, 2023Degraded; Degraded

  IT WAS REPORTED THAT AFTER THE BEGINNING OF THE LITHOTRIPSY, THE FIBER STOPPED WORKING FOR NO APPARENT REASON. THE PROCEDURE WAS COMPLETED USING ANOTHER UNIT. NO PATIENT COMPLICATIONS WERE REPORTED. UPON DEVICE EVALUATION, IT WAS FOUND THAT THE FIBER CONNECTOR WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228776 ↗
• MalfunctionJan 23, 2023Degraded; Degraded

  IT WAS REPORTED THAT AFTER THE BEGINNING OF THE LITHOTRIPSY, THE FIBER STOPPED WORKING FOR NO APPARENT REASON. THE PROCEDURE WAS COMPLETED USING ANOTHER UNIT. NO PATIENT COMPLICATIONS WERE REPORTED. UPON DEVICE EVALUATION, IT WAS FOUND THAT THE FIBER CONNECTOR WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224456 ↗
• MalfunctionJan 23, 2023Degraded; Degraded

  IT WAS REPORTED THAT AFTER THE BEGINNING OF THE LITHOTRIPSY, THE FIBER STOPPED WORKING FOR NO APPARENT REASON. THE PROCEDURE WAS COMPLETED USING ANOTHER UNIT. NO PATIENT COMPLICATIONS WERE REPORTED. UPON DEVICE EVALUATION, IT WAS FOUND THAT THE FIBER CONNECTOR WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224455 ↗
• MalfunctionJun 13, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 28, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A FLEXIBLE URETEROLITHOTRIPSY PROCEDURE TO TREAT RENAL STONES IN THE KIDNEY, PERFORMED ON (B)(6)2021. DURING THE PROCEDURE, THE LASER FIBER WAS LOSING LASER ENERGY UNTIL IT STOPPED FRAGMENTING THE RENAL CALCULUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681965 ↗
• MalfunctionMay 19, 2022Break; Failure to Fire; Optical Problem; Break; Failure to Fire; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 13, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY WITH LITHOTRIPSY PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER CONSOLE UNIT USED WAS A DORNIER H20 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS CONNECTED TO THE LASER HOWEVER, THE GREEN LIGHT DID NOT APPEAR AT THE TIP. THE LASER FIBER DID NOT HAVE ANY EFFECTIVE ACTION ON THE KIDNEY STONES. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434843 ↗
• MalfunctionMay 18, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 13, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY WITH LITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2021. THE LASER CONSOLE UNIT USED WAS A DORNIER H20 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432037 ↗
• MalfunctionMay 18, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 13, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY WITH LITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER HAD INSUFFICIENT ENERGY TO FRAGMENT THE CALCULUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429578 ↗
• MalfunctionMay 18, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 10, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A URETEROLITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING AFTER 7 MINUTES OF LASER ACTIVATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428300 ↗
• MalfunctionMay 18, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A URETEROLITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2021. THE LASER SETTINGS USED WAS 800 JOULES WITH A FREQUENCY OF 8 AND A DENSITY OF 1200HU. DURING THE PROCEDURE, AFTER 15 SECONDS OF USE, THE LASER FIBER HAD A DECREASE IN BRIGHTNESS UNTIL IT NO LONGER FRAGMENTED THE RENAL CALCULUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428218 ↗
• MalfunctionMay 16, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 10, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A URETEROLITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER HAD A DECREASE IN LUMINOSITY AT THE TIP UNTIL IT WENT OUT COMPLETELY, STOPPING THE FRAGMENTATION OF THE RENAL CALCULUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408885 ↗
• MalfunctionMay 16, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 13, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY WITH LITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2021. THE LASER SETTINGS WERE A FREQUENCY OF 8 HERTZ AND 800 JOULES. DURING THE PROCEDURE, THERE WERE NO LASER ENERGY COMING OUT FROM THE LASER FIBER AND AFTER THE FIRST SHOT THE LASER FIBER BURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. 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 14407464 ↗
• MalfunctionMay 14, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT FLEXIVA LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER MALFUNCTIONED. THE GENERATOR WAS CHANGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402817 ↗
• MalfunctionMay 13, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 14, 2021 THAT FLEXIVA LASER FIBER WAS USED IN A PROCEDURE 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 OF LASER FIBER BROKEN WITHIN THE CONNECTOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402376 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 14, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MATERIAL PRESENTED A DEFECT. THERE WAS NO PASSAGE OF THE ENERGY PULSE TO THE CALCULUS FRAGMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366347 ↗
• MalfunctionMay 11, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365989 ↗
• MalfunctionMay 5, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 14, 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A PROCEDURE, PERFORMED ON (B)(6)2021 . DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291135 ↗
• MalfunctionMay 5, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 14, 2021 THAT A FLEXIVA LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE FIBER MALFUNCTIONED AFTER 30 MINUTES OF USAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BODY BROKEN WITHIN THE CONNECTOR AND LASER FIBER BODY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290936 ↗
• MalfunctionApr 29, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING AFTER 30 SECONDS OF USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253140 ↗
• MalfunctionApr 21, 2022Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA HIGH POWER SINGLE USE LASER FIBER WAS USED IN A LITHIASIS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FLEXIVA LASER FIBER MADE AN ABNORMAL NOISE AND BECAME HOT. THE PHYSICIAN SMELLED A BURNING A SMELL. 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168089 ↗
• MalfunctionMar 11, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 14, 2021 THAT A FLEXIVA LASER FIBER WAS USED DURING A PROCEDURE , PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE FIBER STOPPED WORKING THREE TIMES AND DID NOT WORK ANYMORE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR AND FIBER BODY WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731578 ↗
• MalfunctionMar 11, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 28, 2021 THAT A FLEXIVA LASER FIBER WAS USED DURING A FLEXIBLE UTERINE AND TUBAL LAVAGE PROCEDURE TO AN 8MM, 650 HU RENAL CALCULUS IN THE RIGHT MIDDLE URETER, PERFORMED ON (B)(6) 2021. THE LASER SETTING WAS 8.0 WATTS. DURING THE PROCEDURE, WHEN FRAGMENTATION WAS STARTED, THE LASER FIBER STOPPED WORKING AFTER 5 MINUTES OF LASER ACTIVATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. 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 13731574 ↗
• MalfunctionFeb 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA 200 LASER FIBER WAS USED IN A PROCEDURE IN THE KIDNEY PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER WAS 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: Insufficient Information

  MAUDE report 13567562 ↗
• MalfunctionDec 17, 2021Degraded; Overheating of Device; Detachment of Device or Device Component; Degraded; Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS P120 LASER CONSOLE WITH LASER SETTINGS OF 1.80 HERTZ, 0.3 JOULES AND 10HERTZ, 0.8 JOULES. DURING THE PROCEDURE, THE FIBER CONNECTOR WAS HOT AND A STAFF MEMBER RECEIVED A BURN TO HER FINGER FROM THE HOT LASER FIBER CONNECTOR WHEN REMOVING THE FIBER FROM THE LASER CONSOLE. THE LASER FIBER RUBBER BOOT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE STAFF MEMBERS BURNT FIBER WAS TREATED WITH COLD WATER.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025669 ↗
• MalfunctionDec 7, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 14, 2021 THAT A FLEXIVA 200 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PROBLEM WITH THE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 12955790 ↗