Flexiva™ ID M006R8403940Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729963813), received between Jul 26, 2018 and Jul 5, 2022 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA ID LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. A STENT WAS PLACE TO ALLOW THE KIDNEY TO DRAIN. THE PROCEDURE, WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914282 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A LITHOPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. DURING THE PROCEDURE, IN THE INITIAL FIRING THE LASER FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12594953 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-04901 FOR THE FIRST FLEXIVA ID 1000 LASER FIBER AND MFR REPORT #3005099803-2021-04922 FOR THE SECOND FLEXIVA ID 1000 LASER FIBER . IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF. A SECOND LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. THE TIPS BROKE OFF OUTSIDE THE PATIENT AND THE FIBERS WERE NOT STRIPPED OR CLEAVED BEFORE THEY BROKE. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523520 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-04901 FOR THE FIRST FLEXIVA ID 1000 LASER FIBER AND MFR REPORT #3005099803-2021-04922 FOR THE SECOND FLEXIVA ID 1000 LASER FIBER . IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 1, 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF. A SECOND LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. THE TIPS BROKE OFF OUTSIDE THE PATIENT AND THE FIBERS WERE NOT STRIPPED OR CLEAVED BEFORE THEY BROKE. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523510 ↗
• MalfunctionJun 24, 2021Break; Failure to Fire; Material Deformation; Break; Failure to Fire; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN CYSTOLITHOLAPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A MOSES LASER 1.0 LASER CONSOLE. DURING THE PROCEDURE, THE DEVICE HAS NO ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060040 ↗
• MalfunctionFeb 25, 2021Melted; Overheating of Device; Material Deformation; Melted; Overheating of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 2, 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 WATT LASER CONSOLE. DURING THE PROCEDURE, WHEN CONNECTING THE LASER FIBER, THE PHYSICIAN NOTICED THAT IT WAS WARM TO TOUCH. THE PHYSICIAN RECONNECTED THE LASER FIBER AND NOTED THAT THE CONNECTOR WAS BURNED AND RESHAPED AT THE TIP. REPORTEDLY, THERE WAS NO BURN INJURY TO THE PATIENT OR TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378707 ↗
• MalfunctionNov 12, 2020Defective Device

  BOSTON SCIENTIFIC FLEXIVA ID HIGH POWER SINGLE-USE LASER FIBER DIDN'T LAST THE WHOLE CASE, AND STAFF NEEDED TO OPEN A NEW DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 10828637 ↗
• MalfunctionJun 10, 2020Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL OF THE LASER UNIT, THERE WAS VERY LITTLE ENERGY COMING OUT FROM THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 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 TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10139034 ↗
• MalfunctionApr 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 11, 2020 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE LASER UNIT USED WAS A P100 LASER CONSOLE WITH LASER SETTINGS OF 1.2 JOULES AND 10 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER TIP BROKE OFF INSIDE THE PATIENT UPON LASER ACTIVATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. 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 Consequences Or Impact To Patient

  MAUDE report 9920352 ↗
• MalfunctionApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE IN THE BLADDER PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BLEW UP AFTER A MINUTE OF USE. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9917094 ↗
• MalfunctionJan 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 27, 2019 THAT A FLEXIVA ID 1000 LASER FIBERS WAS USED DURING A CYSTOLITHOLAPAXY PROCEDURE IN THE URINARY "BLADDDER" PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER WAS FRACTURED AFTER 30 SECONDS OF USE. A SECOND OF THE SAME DEVICE WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE SECOND BROKEN TIP FLEXIVA ID 1000 LASER FIBER. REPORTEDLY, THERE WERE NO RETAIN TIPS IN THE PATIENT. 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 9626974 ↗
• MalfunctionJan 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 27, 2019 THAT A FLEXIVA ID 1000 LASER FIBERS WAS USED DURING A CYSTOLITHOLAPAXY PROCEDURE IN THE URINARY "BLADDDER" PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER WAS FRACTURED AFTER 30 SECONDS OF USE. A SECOND OF THE SAME DEVICE WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE SECOND BROKEN TIP FLEXIVA ID 1000 LASER FIBER. REPORTEDLY, THERE WERE NO RETAIN TIPS IN THE PATIENT. 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 9626972 ↗
• MalfunctionOct 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2019 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A CYSTOSCOPY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. A SECOND AND A THIRD OF THE SAME DEVICE WERE USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH FLEXIVA ID 1000 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 9180050 ↗
• MalfunctionOct 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2019 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A CYSTOSCOPY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. A SECOND AND A THIRD OF THE SAME DEVICE WERE USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH FLEXIVA ID 1000 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 9180046 ↗
• MalfunctionOct 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 18, 2019 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A CYSTOSCOPY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. A SECOND AND A THIRD OF THE SAME DEVICE WERE USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH FLEXIVA ID 1000 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 9174496 ↗
• InjuryJun 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. A CYSTOSCOPE WAS DONE TO RETRIEVED THE TIP. EXAMINATION REVEALED THERE WAS NO LASER TIP INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8667354 ↗
• MalfunctionMay 8, 2019Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 19, 2019 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A URETEROSCOPY WITH LASER PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 CONSOLE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591045 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-02420 AND 3005099803-2018-02421 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE FLEXIVA ID 1000 LASER FIBERS WERE USED DURING A PROCEDURE IN THE KIDNEY AND BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 WITH MOSES CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE TIP OF THE LASER FIBERS DETACHED AFTER 1 TO 2 MINUTES OF USE. 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. 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 7722576 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-02421 AND 3005099803-2018-02422 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE FLEXIVA ID 1000 LASER FIBERS WERE USED DURING A PROCEDURE IN THE KIDNEY AND BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 WITH MOSES CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE TIP OF THE LASER FIBERS DETACHED AFTER 1 TO 2 MINUTES OF USE. 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. 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 7722568 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-02420 AND 3005099803-2018-02422 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE FLEXIVA ID 1000 LASER FIBERS WERE USED DURING A PROCEDURE IN THE KIDNEY AND BLADDER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 WITH MOSES CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE TIP OF THE LASER FIBERS DETACHED AFTER 1 TO 2 MINUTES OF USE. 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. 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 7722567 ↗