AccuMax M0068404040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729784616), received between Aug 22, 2017 and Feb 11, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 28, 2019Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FOURTH OF FOUR ACCUMAX LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 1000 LASER FIBER WAS USED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER DID NOT LAST VERY LONG AND HAD TO BE REPLACED WITHIN AN UNUSUALLY SHORT TIMEFRAME. IT WAS NOTED THAT THE TIP OF THE LASER FIBER WAS USED UP MUCH FASTER THAN NORMAL. A SECOND, THIRD, AND FOURTH ACCUMAX 1000 LASER FIBER WERE OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FIFTH ACCUMAX 1000 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 TIP DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380431 ↗
• MalfunctionFeb 28, 2019Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE THIRD OF FOUR ACCUMAX LASER FIBERS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUMAX 1000 LASER FIBER WAS USED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER DID NOT LAST VERY LONG AND HAD TO BE REPLACED WITHIN AN UNUSUALLY SHORT TIMEFRAME. IT WAS NOTED THAT THE TIP OF THE LASER FIBER WAS USED UP MUCH FASTER THAN NORMAL. A SECOND, THIRD, AND FOURTH ACCUMAX 1000 LASER FIBER WERE OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FIFTH ACCUMAX 1000 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 TIP DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380426 ↗
• MalfunctionSep 26, 2018Output Problem

  WHEN WE BEGAN THE TURP, THE DOCTOR FOUND A FEW HUGE BLADDER STONES THAT HE USED THE HOLMIUM LASER FOR TO BREAK UP THE STONES. IT TOOK SEVERAL HOURS TO BREAK UP THE STONES. WE WENT THROUGH FIVE LASER FIBERS; FOUR OF THE FIBERS DID NOT LAST VERY LONG AND HAD TO BE REPLACED WITHIN AN UNUSUALLY SHORT TIMEFRAME. THE TIP OF THE LASER FIBER WAS USED UP MUCH FASTER THAN NORMAL ACCORDING TO THE SURGEON. ALL FOUR LASER FIBERS THAT WERE OF SHORT DURATION WERE SAVED, WITH ALL THE PACKAGES.

  Patient problems: No Information

  MAUDE report 7909367 ↗
• MalfunctionAug 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ACCUMAX 1000 LASER FIBER WAS USED DURING A URETEROSCOPIC STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LASER POWER SETTING WAS 10 WATTS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE FIBER DETACHED INSIDE THE PATIENT AFTER A FEW SECONDS OF LASERING. THE BLADDER WAS IRRIGATED AND THE BROKEN TIP WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUMAX 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AFTER THE PROCEDURE WAS REPORTED TO BE ¿NO PATIENT CONCERN¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811478 ↗