AccuMaxRecalls & reported problems across all models

We found 4 models of AccuMax by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2016 and Oct 22, 2024 — classified as 5 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 AccuMax problems

AccuMax models

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

• AccuMax M0068404010

  Powered laser surgical instrument
  51 reports
• AccuMax M0068404020

  Powered laser surgical instrument
  17 reports
• AccuMax M0068404030

  Powered laser surgical instrument
  15 reports
• AccuMax M0068404040

  Powered laser surgical instrument
  6 reports

Recent AccuMax adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ACCUMAX LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE FOR A LITHIASIS RENAL TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN EMS 20 WATTS LASER CONSOLE. DURING PROCEDURE, THE LASER FIBER WAS MORE SENSITIVE TO USE AND THE FIBER BODY BROKE TWICE. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283234 ↗
• InjuryNov 29, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A FLEXIBLE COLEDOCOLITHOTRIPSY PROCEDURE TO TREAT GALLSTONES, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE LASER FIBER REACHED THE DISTAL END OF THE SCOPE WORKING CHANNEL, THE DISTAL PART OF THE LASER FIBER BROKE. THE PHYSICIAN RETRIEVED THE BROKEN PIECE OF THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885160 ↗
• 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 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A HOLMIUM LASER CONSOLE. PRIOR TO PROCEDURE, IT WAS FOUND THAT THE LASER FIBER WAS FRACTURED AND THERE WAS NO LASER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 12594721 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 11, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC ON JANUARY 18, 2021 THAT AN ACCUMAX 1000 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE COATING NEAR THE FIBER TIP WAS COMING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS RETURNED AND INVESTIGATION REVEALED THE LASER FIBER TIP DETACHED AND THE LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317360 ↗
• MalfunctionDec 28, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ACCUMAX 1000 LASER FIBER WAS USED IN A CYSTOLITHALOPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT WAS A LUMENIS VERSAPULSE 60 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE FIBER WAS NO LONGER WORKING. WHEN THEY REMOVED THE FIBER TO INSPECT THE TIP, THEY NOTICED THAT THE TIP WAS MISSING. REPORTEDLY, NO FRAGMENTS FELL OFF INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11080503 ↗
• MalfunctionJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A LITHOTRIPSY WITH HOLMIUM LASER PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER NEAR THE TIP 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: No Known Impact Or Consequence To Patient

  MAUDE report 10219203 ↗
• InjuryJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A LITHOTRIPSY WITH HOLMIUM LASER PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER 60 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER NEAR THE TIP BROKE OFF INSIDE THE PATIENT. REPORTEDLY, THE FIBER FRAGMENT WAS RETRIEVED SUCCESSFULLY WITH A GRASPIT RETRIEVAL DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217807 ↗
• 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 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports