AccuMax M0068404030Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729784609), received between Apr 10, 2018 and Oct 22, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 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 FIBER DID NOT WORK WHEN PERFORMING THE TEST WITH THE EQUIPMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITH NO PATIENT COMPLICATIONS. THE FIBER WAS RETURNED, AND ANALYSIS IDENTIFIED A FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507153 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ACCUMAX LASER FIBER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE FOR A LITHIASIS RENAL TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN ACCUTECH 60 WATTS LASER CONSOLE. DURING PROCEDURE, THE LASER FIBER PRESENTED A LOT OF FRAGILITY AND BROKE. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TYPE OF DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287863 ↗
• MalfunctionApr 15, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ACCUMAX 550 LASER FIBER WAS USED IN A LASER NEPHROLITHOTOMY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. THE LASER UNIT USED WAS A SPHINX JR LASER CONSOLE. DURING THE PROCEDURE, A NEW LASER FIBER WAS PASSED AND CALCULATION FRAGMENTATION BEGAN. AFTER A FEW MINUTES, THE FIBER STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 11671272 ↗
• MalfunctionJun 3, 2020Break; Failure to Fire; Detachment of Device or Device Component; Break; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ACCUMAX 550 LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE FOR A STONE IN THE KIDNEY PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE INDICATOR LIGHT WAS NOT ON AND THERE WAS NO RESPONSE WHEN THE FOOT PEDAL WAS STEPPED ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 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 AND FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10116379 ↗
• MalfunctionApr 20, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 31, 2020 THAT AN ACCUMAX 550 LASER FIBER WAS USED IN A URETERAL LITHOTOMY UNDER RIGID URETEROSCOPIC PROCEDURE FOR A STONE IN THE KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CONNECTOR OF THE LASER FIBER WAS HOT AND COULD NOT BE USED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 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 9977036 ↗
• MalfunctionApr 9, 2020Break; Failure to Fire; Detachment of Device or Device Component; Break; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 23, 2019 THAT AN ACCUMAX 550 LASER FIBER WAS USED IN A RENAL PELVIS LASER LITHOTRIPSY PROCEDURE FOR CALCULUS IN THE PELVIS PERFORMED ON (B)(6) 2019. REPORTEDLY THE LASER UNIT WAS A KEYIREN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INDICATOR LIGHT OF THE LASER FIBER WAS NOT SEEN AFTER IT WAS CONNECTED TO THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE LASER FIBER BROKEN WITHIN THE CONNECTOR AND FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9945867 ↗
• MalfunctionSep 11, 2019Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 28, 2019 THAT AN ACCUMAX 550 SINGLE USE LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER DID NOT FRAGMENT THE STONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 SINGLE USE LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN SMA CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8994669 ↗
• MalfunctionFeb 27, 2019Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 550 LASER FIBER WAS USED FOR AN F-URS PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE LASER FIBER HAD NO ENERGY OUTPUT WHEN IT WAS CONNECTED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374001 ↗
• MalfunctionFeb 11, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ACCUMAX 550 LASER FIBER WAS OPENED FOR IN A URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CONNECTOR OF THE LASER FIBER WAS HOT AFTER IT WAS CONNECTED TO THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 8325571 ↗
• MalfunctionNov 21, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 550 LASER FIBER WAS USED IN A STONE RUBBLE PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE TIP OF THE LASER FIBER WAS NOTED TO HAVE BLACK SPOTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096359 ↗
• MalfunctionOct 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT TWO ACCUMAX 550 LASER FIBERS WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE LASER FIBER BROKE UPON FIRING. A SECOND ACCUMAX 550 LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8010663 ↗
• MalfunctionOct 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT TWO ACCUMAX 550 LASER FIBERS WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE LASER FIBER BROKE UPON FIRING. A SECOND ACCUMAX 550 LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8010660 ↗
• MalfunctionOct 15, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 550 LASER FIBER WAS USED DURING URETEROLITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTED THAT THE TIP OF THE LASER FIBER BURNT OUT WHILE IT WAS CONNECTED WITH THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 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 STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THERE WAS DEBRIS ON THE FIBER FACE WITHIN THE SMA CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7964983 ↗
• MalfunctionAug 7, 2018Misfire; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 550 LASER FIBER WAS USED DURING A URETERAL LITHOTOMY UNDER RIGID URETEROSCOPIC PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTED THAT THE LASER FIBER SHORT CIRCUITED AND SPARKS WERE OBSERVED NEAR THE CONNECTOR. ADDITIONALLY, THE LASER FIBER STOPPED FIRING AT THIS TIME. THERE WAS NO BURN INJURY TO THE NURSE/PHYSICIAN. THE PROCEDURE COMPLETED WITH ANOTHER ACCUMAX 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757905 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 550 LASER FIBER WAS OPENED FOR USE IN A PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS DORNIER MEDIALIX H20 CONSOLE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE OPERATOR OF THE DEVICE NOTED THAT THE AIMING BEAM WAS COMING OUT FROM THE MIDDLE OF THE FIBER AND NOT FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 550 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS 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 7414237 ↗