FlexivaRecalls & reported problems across all models

We found 4 models of Flexiva by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 481 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2017 and Jun 8, 2023 — classified as 25 injuries, 456 malfunctions.

The most frequently reported specific device problem is “Break” (343 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Flexiva problems

Flexiva models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Flexiva M0068403910

  Powered laser surgical instrument
  376 reports
• Flexiva M0068403920

  Powered laser surgical instrument
  52 reports
• Flexiva M0068403940

  Powered laser surgical instrument
  31 reports
• Flexiva M0068403930

  Powered laser surgical instrument
  22 reports

Recent Flexiva adverse event reports

The 15 most recent reports across all models, 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 ↗

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