Flexiva Pulse M006L8405940Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729978602), received between Jun 17, 2022 and Jun 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Melted; Overheating of Device; Melted; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 23, 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN LUMENIS PULSE 100H LASER CONSOLE. THE LASER SETTINGS FOR THE RIGHT SIDE WERE A FREQUENCY OF 8 HERTZ , 0.8 JOULES AND 6.4 WATTS AND FOR THE LEFT SIDE WERE A FREQUENCY OF 35 HERTZ , 1.8 JOULES AND 72 WATTS. DURING THE PROCEDURE, THE PLASTIC PART OF THE LASER FIBER WAS HOT AND MELTED. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. 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 14733722 ↗