Flexiva™ ID M006R8403930Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729963790), received between May 31, 2018 and Jun 27, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LASER FIBER WAS NOT TRANSMITTING PROPERLY. NO PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629169 ↗
• MalfunctionAug 27, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 9, 2021 THAT A FLEXIVA ID 550 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS MOSES 2.0 LASER CONSOLE WITH LASER SETTINGS OF 2 JOULES AND 50 HERTZ. DURING THE PROCEDURE, DEBRIS WERE FOUND IN THE BLAST SHIELD AND WAS SEVERELY DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: 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 12379099 ↗
• MalfunctionMay 11, 2020Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 6, 2020 THAT A FLEXIVA ID 550 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 LASER CONSOLE WITH LASER SETTINGS OF 2 JOULES AND 8 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS PLUGGED INTO THE LASER UNIT AND WAS MAKING A CRACKLING SOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 550 LASER FIBER. 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 FINE. 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 10044983 ↗
• MalfunctionMar 5, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FIFTH OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. 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 9792443 ↗
• MalfunctionMar 4, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SIXTH OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. 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 9788584 ↗
• MalfunctionMar 4, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. 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 9788539 ↗
• MalfunctionMar 4, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FOURTH OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. 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 9788538 ↗
• MalfunctionMar 4, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. 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 9788536 ↗
• MalfunctionMar 4, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF SEVEN DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2020 THAT FIVE FLEXIVA ID 550 LASER FIBERS AND ONE FLEXIVA ID 365 LASER FIBER WERE USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN LASER FIBERS BURNED BACK VERY FAST AND THE TIPS BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. 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 9788535 ↗
• MalfunctionFeb 24, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 4, 2020 THAT A FLEXIVA ID 550 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE IN PROSTATE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 20 WATT LASER CONSOLE WITH SETTINGS OF: 2 JOULES WITH 60 HERTZ, 2 JOULES WITH 20 HERTZ AND 1.5 JOULES WITH 30 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT FIRING PROPERLY AND THE CONNECTOR WAS NOTED TO BE HOT. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 550 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 9746528 ↗
• MalfunctionDec 5, 2019Misfire; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 11, 2019 THAT A FLEXIVA ID LASER FIBER WAS USED IN A LITHOLAPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A POPPING SOUND AND FLASH OF LIGHT AT THE CONNECTION HUB WHEN THE SURGEON PRESSED ON THE PEDAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS 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 9415713 ↗
• MalfunctionJul 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 ID 550 LASER FIBER USED IN A CYSTOLITHOLAPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A P100 LASER CONSOLE WITH LASER SETTINGS OF 1 JOULE AND 50 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. REPORTEDLY, THE FIBER TIP WAS RETRIEVED SUCCESSFULLY BY FLUSHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 550 LASER FIBER. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786050 ↗
• MalfunctionJun 24, 2019Output Problem

  PRIOR TO USE IN PATIENT, THE CIRCULATING NURSE NOTED THAT LASER FIBER WIRE WAS NOT WORKING PROPERLY. THE LASER FIBER WIRE WAS REMOVED FROM THE STERILE FIELD AND SEQUESTERED UNTIL GIVEN TO MANAGEMENT FOR FOLLOW UP. THE CIRCULATING NURSE GAVE A NEW LASER FIBER WIRE TO THE SURGEON AND THE CASE CONTINUED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726953 ↗
• MalfunctionMay 22, 2019Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA ID 550 LASER FIBER WAS USED IN A PROSTATE NUCLEATION PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN AND LASER ENERGY ESCAPED CAUSING TO BURN TWO HOLES ON THE DRAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 550 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633569 ↗
• MalfunctionMay 22, 2019Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 2, 2019 THAT A FLEXIVA ID 550 LASER FIBER WAS USED IN A PROSTATE NUCLEATION PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6)2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN AND LASER ENERGY ESCAPED CAUSING TO BURN TWO HOLES ON THE DRAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 550 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633567 ↗
• InjuryJan 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 7, 2019 THAT A FLEXIVA ID 550 LASER FIBER WAS USED DURING A RIGID BRONCHOSCOPY, LASER ABLATION, MECHANICAL DEBULKING, ELECTROCAUTERY SNARE, BALLOON DILATION, STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS PLACED IN THE BRONCHOSCOPE CHANNEL WITH TIP REMAINING INTACT. THE CHANNEL WAS REMOVED AS PLANNED. AFTER RE-INTRODUCING THE FIBER IT WAS NOTED THAT THE TIP WAS FRACTURED. THE TIP WAS FOUND BURIED IN THE AIRWAY MUCOSA LATER ON AND WAS RETRIEVED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH A SECOND FLEXIVA ID 550 LASER FIBER THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281700 ↗
• MalfunctionDec 18, 2018Fracture

  LASER FIBER WAS PLACED THROUGH THE BRONCHOSCOPE CHANNEL WITH TIP REMAINING INTACT. AFTER BRIEF USAGE IT WAS REMOVED FROM THE CHANNEL AS PLANNED. AFTER RE-INTRODUCING THE FIBER IT WAS NOTED THAT THE TIP WAS FRACTURED. A NEW LASER FIBER WAS OPENED AND USED THEREAFTER. THE TIP WAS LATER FOUND BURIED IN THE AIRWAY MUCOSA AND WAS RETRIEVED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174341 ↗
• MalfunctionJun 28, 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 ID 550 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS MOSES P120 CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTED THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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. 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 7645725 ↗
• MalfunctionMay 31, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 550 LASER FIBER WAS USED DURING A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS LUMENIS P100 LASER CONSOLE WITH SETTINGS OF 1.5 JOULES AND 20 HERTZ. ACCORDING TO THE COMPLAINANT, ABOUT 15 MINUTES INTO THE PROCEDURE, THE OPERATOR ATTEMPTED TO ADVANCE THE FIBER IN THE WORKING CHANNEL OF THE SCOPE WHEN THE PROTECTIVE COATING OF THE LASER FIBER SHEARED A LITTLE BIT AND THE FIBER BODY BROKE INSIDE THE WORKING CHANNEL OF THE CYSTOSCOPE. THE LASER FIBER WAS TAKEN OUT FROM THE SCOPE AND SCRAPE MARKS WERE NOTED INSIDE THE WORKING CHANNEL OF THE CYSTOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 7558091 ↗