AccuMax M0068404010Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 08714729784586), received between Dec 27, 2016 and May 4, 2022 — classified as 5 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionNov 22, 2019Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ACCUMAX LASER FIBER WAS USED DURING A LITHOTRIPSY UNDER URETEROSCOPIC BY HOLMIUM LASER PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE FIBER BODY BECAME EXOTHERMIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9362331 ↗
• MalfunctionNov 20, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A LITHOTRIPSY HOLMIUM LASER UNDER FLEXIBLE URETEROSCOPIC PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER CONNECTOR OVERHEATED AND COULD NOT BE USED. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER. 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 9347781 ↗
• InjuryOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 26, 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE LEFT KIDNEY PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER BROKE INSIDE THE PATIENTS LEFT KIDNEY. BOSTON SCIENTIFIC HAS BEEN UNABLE 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 9205263 ↗
• MalfunctionAug 26, 2019Break; 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) 2019 THAT AN ACCUMAX 200 SINGLE LASER FIBER WAS OPENED FOR USE FOR A SOFT URETERAL MANAGEMENT OF UPPER URETERAL STONE PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THERE WAS NO LASER ENERGY COMING OUT FROM THE LASER FIBER UPON CONNECTING TO THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 SINGLE LASER FIBER. THERE WAS 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 LASER FIBER WAS BROKEN WITHIN THE SMA CONNECTOR AND TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932309 ↗
• MalfunctionJun 11, 2019Overheating of Device; Failure to Fire; Overheating of Device; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 17, 2019 THAT AN ACCUMAX 200 LASER FIBER USED IN A LASER LITHOTRIPSY UNDER FLEXIBLE URETEROSCOPIC PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA 100W LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, HEAT WAS FELT ON THE LASER FIBER AND THERE WAS NO ENERGY COMING OUT FROM THE FIBER TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 8687671 ↗
• MalfunctionJun 3, 2019Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A FLEXIBLE URETEROSCOPY (FURS) WITH KIDNEY STONE PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER MEDILAS H20 LASER CONSOLE WITH LASER SETTINGS OF 6 WATTS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT GIVING ENOUGH LASER ENERGY AFTER 10 MINUTES OF USE AND THE CONNECTOR OF THE FIBER WAS NOTED TO BE VERY HOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WERE NO PATIENT OR USER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663176 ↗
• InjuryMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 5, 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A URETERAL LITHOTOMY UNDER FLEXIBLE URETEROSCOPIC PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE INDICATOR LIGHT OF THE DEVICE TURNED OFF ABOUT TEN MINUTES INTO THE PROCEDURE. UPON EXAMINATION, THE PHYSICIAN FOUND A FRACTURED PART OF THE FIBER INSIDE THE PATIENT'S BODY. REPORTEDLY, IT WAS THE TIP OF THE FIBER AND IT WAS WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 8650178 ↗
• MalfunctionMay 13, 2019Break; Break

  THIS REPORT PERTAINS TO THE SECOND OF TWO ACCUMAX 200 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO ACCUMAX 200 LASER FIBERS WERE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST LASER FIBER WAS BROKEN DURING USAGE. A SECOND OF THE SAME DEVICE 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 SUPPLEMENT REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8605043 ↗
• MalfunctionMay 13, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ACCUMAX 200 LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO ACCUMAX 200 LASER FIBERS WERE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST LASER FIBER WAS BROKEN DURING USAGE. A SECOND OF THE SAME DEVICE 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 SUPPLEMENT REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8605004 ↗
• MalfunctionApr 24, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ON LASER ACTIVATION, THE BODY OF THE LASER FIBER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545114 ↗
• MalfunctionApr 23, 2019Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER LASER CONSOLE. ACCORDING THE COMPLAINANT, DURING PROCEDURE, WHILE FIRING THE LASER FIBER, THE FIBER BROKE AND A HOLE WAS CREATED IN THE NAVIGATOR SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 8540665 ↗
• MalfunctionFeb 26, 2019Misfire; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 5, 2019 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A CYSTOSCOPY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER 30 WATT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BURST OF LASER ENERGY AND LIGHT WAS NOTED UPON PRESSING DOWN THE FOOT PEDAL AND THE LASER STOPPED FIRING. THE LASER FIBER WAS UNPLUGGED AND PLUGGED BACK IN BUT IT STILL DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371166 ↗
• MalfunctionDec 20, 2018Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 26, 2018 THAT AN ACCUMAX 200 LASER FIBER WAS OPENED FOR USE FOR A URS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE LASER FIBER BROKE CAUSING A BURN TO THE USER'S THIRD FINGER ON THEIR RIGHT HAND AND BURNT A HOLE IN THE DRAPE. THE BURN WAS TREATED WITH COLD WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 08JAN2018: THE PROCEDURE PERFORMED IN THE URETER/KIDNEY USING A LUMENIS P20 CONSOLE WITH LASER SETTINGS OF 0.6 HERTZ AND 1.2 JOULES. THE EVENT OCCURRED DURING THE PROCEDURE.

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

  MAUDE report 8186364 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 200 LASER FIBER WAS OPENED FOR USE IN A URETEROSCOPY PROCEDURE PERFORMED IN THE KIDNEY ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE LASER FIBER WAS NOTED TO BE BROKEN BETWEEN THE CONNECTOR AND THE FIBER BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 8154882 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE TIP OF THE LASER FIBER WAS NOTED TO BE BROKEN STRAIGHT FROM THE PACKAGE. 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 8013608 ↗
• MalfunctionOct 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 2, 2018 THAT AN ACCUMAX LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE TIP OF THE LASER FIBER WAS NOTED TO BE BROKEN STRAIGHT FROM THE PACKAGE. 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 8010861 ↗
• 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 AN ACCUMAX LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE TIP OF THE LASER FIBER WAS NOTED TO BE BROKEN STRAIGHT FROM THE PACKAGE. 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 8010661 ↗
• MalfunctionJul 17, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A CYSTOSCOPY, URETEROSCOPY, STONE REMOVAL AND STENT PLACEMENT PROCEDURE IN THE BLADDER AND URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS DORNIER 20 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE PHYSICIAN NOTED THAT THE LASER FIBER WAS NOT EMITTING ENOUGH LASER ENERGY TO BREAK THE STONE EVEN AFTER INCREASING THE LASER SETTINGS TO 1 JOULE. THE NURSE REMOVE THE LASER FIBER AND NOTED THAT THE FIBER CONNECTOR WAS HOT TO TOUCH. REPORTEDLY, THE NURSE WAS NOT BURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694593 ↗
• MalfunctionJun 27, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE NURSE NOTED THAT THERE WAS NO LASER ENERGY COMING OUT FROM THE FIBER WHEN CONNECTED TO THE LASER CONSOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 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. 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 7642063 ↗
• InjuryJun 18, 2018Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 22, 2018 THAT AN ACCUMAX 200 LASER FIBER WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE RENAL PELVIS OF THE KIDNEY PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A 20 WATT HOLMIUM CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER TIP SUDDENLY EXPLODED DURING USE AND DAMAGED THE SCOPE. IT WAS ALSO NOTED THAT THE BLUE CLADDING FROM THE FIBER WAS FOUND IN THE RENAL PELVIS. ATTEMPTS TO RETRIEVE THE CLADDING USING A BASKET AND GRASPER WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 200 LASER FIBER. A STENT WAS PLACED AT THE END OF THE PROCEDURE AND THE PATIENT WAS REFERRED TO ANOTHER FACILITY TO REMOVE THE CLADDING AS THE PHYSICIAN DID NOT BELIEVE IT WOULD NATURALLY PASS OUT. 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 7610598 ↗