AccuMax M0068404020Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729784593), received between Jun 2, 2017 and May 5, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER WAS USED IN A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, LEFT URETEROSCOPY, HOLMIUM LASER ABLATION LEFT STONE WITH BASKET STONE EXTRACTION, AND LEFT URETERAL STENT PROCEDURE PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS PULSE 100 WATT HOLMIUM LASER WITH LASER SETTINGS OF 1.4 JOULES WITH A TOTAL OF 5 KILOJOULES. DURING PROCEDURE, THE LASER FIBER BROKE WHILE IN USE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287235 ↗
• MalfunctionOct 26, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUMAX LASER FIBER WAS OPENED PRIOR TO A PROCEDURE PERFORMED ON (B)(6) 2021. UPON OPENING THE PACKAGE, THE PHYSICIAN ASSISTANT (PA) NOTICED THAT THE FIBER WAS BROKEN IN THE MIDDLE OF THE FIBER BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 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 TIP CHIPPED/DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698894 ↗
• MalfunctionAug 12, 2021Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ACCUMAX 365 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN WENT TO USE THE LASER FIBER THERE WAS A POOPED SOUND HEARD AND IT WAS THEN NO LONGER ABLE TO BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 365 LASER FIBER. 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 AND FIBER BODY BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313594 ↗
• MalfunctionJul 15, 2019Break; Degraded; Overheating of Device; Break; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A ACCUMAX 365 LASER FIBER USED IN A LASER LITHOTRIPSY AND URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS NO LONGER HITTING THE STONE. THE NURSE PLACED THE LASER FIBER ON STANDY AND WHEN THEY TOUCHED THE CUPLER THEIR FINGER WAS BURNED. REPORTEDLY, THE LASER FIBER WAS NOTED TO BE FRACTURED NEAR THE CUPLER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s); No Known Impact Or Consequence To Patient

  MAUDE report 8790717 ↗
• MalfunctionMar 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO ACCUMAX 365 LASER FIBERS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO ACCUMAX 365 LASER FIBERS WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE LASER FIBER DETACHED. ANOTHER ACCUMAX 365 LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ACCUMAX 365 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 8424419 ↗
• MalfunctionMar 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO ACCUMAX 365 LASER FIBERS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO ACCUMAX 365 LASER FIBERS WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE LASER FIBER DETACHED. ANOTHER ACCUMAX 365 LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ACCUMAX 365 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 8424407 ↗
• MalfunctionNov 28, 2018Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A LEFT URETEROSCOPY WITH LASER PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM YAG 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS NO LASER ENERGY COMING OUT FROM THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 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 FIBER WAS BROKEN WITHIN THE SMA CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112788 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 365 LASER FIBER WAS USED IN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS BROKEN. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS 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 7852688 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 18, 2018 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A URETEROSCOPY WITH HOLMIUM LASER PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE PHYSICIAN NOTED THAT THERE WAS NO AIMING BEAM FROM THE LASER FIBER. REPORTEDLY, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 365 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 FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715717 ↗
• MalfunctionMay 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 12, 2018 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A CYSTO STONE PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE AND INSIDE THE PATIENT, THE CLEAR TIP OF THE LASER FIBER BROKE OFF. 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 7484644 ↗
• MalfunctionDec 14, 2017Break; Melted; Misfire; Break; Melted; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER FAILED TO WORK. SMOKE WAS NOTED COMING FROM THE SMA CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 365 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE FIBER WAS BROKEN UNDERNEATH THE BLACK STRAIN RELIEF BOOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7118061 ↗
• MalfunctionDec 12, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ACCUMAX 365 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE AND OUTSIDE THE PATIENT, THE LASER FIBER BROKE AFTER BEING USED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 7109674 ↗
• MalfunctionNov 10, 2017Break; Break

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT 3005099803-2017-03366 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT TWO ACCUMAX 365 LASER FIBERS WERE OPENED FOR USE IN A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE LASER FIBER BROKE WHEN INSERTED INTO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017815 ↗
• MalfunctionOct 10, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE FIBER WAS CONNECTED INTO THE LASER CONSOLE AND WAS NOT RECOGNIZED BY THE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 365 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 STABLE. 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 6936915 ↗
• MalfunctionSep 13, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE LEFT URETER PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LASER UNIT USED WAS 30 WATT QUANTA LASER CONSOLE WITH LASER SETTINGS OF 0.8 JOULES, 8 HERTZ AND 6.4 WATTS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE FIBER WAS PLUGGED INTO THE LASER CONSOLE FOR TESTING AND UPON FIRING LASER ENERGY THERE WAS A LOUD POPPING SOUND AND A POSSIBLE SMELL OF SMOKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 365 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 6863342 ↗
• MalfunctionJul 20, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 20, 2017 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A URETHROTOLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE AND INSIDE THE PATIENT, NO LASER ENERGY WAS COMING OUT FROM THE LASER FIBER WHILE IT WAS CONNECTED TO THE LASER CONSOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 365 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 STABLE. 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 6728770 ↗
• MalfunctionJun 2, 2017Misfire; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ACCUMAX 365 LASER FIBER WAS USED DURING A URETERAL SOFT LENS LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 30W. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, LASER ENERGY WAS SEEN EXITING OUTSIDE OF ITS INTENDED TIP LOCATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6609207 ↗