Optilite G48614Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002486140), received between Apr 21, 2016 and Jun 5, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2020Crack; Crack

  IT WAS REPORTED THAT DURING A LASER FLEXIBLE URETERORRENOLITHOTRIPSY, AN OPTILITE SINGLE-USE HOLMIUM LASER FIBER WAS USED AND BURNT DURING THE PROCEDURE. ANOTHER FIBER WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10123189 ↗
• MalfunctionFeb 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A LASER FLEXIBLE URETERORRENOLITOTRIPSY, A OPTILITE SINGLE-USE HOLMIUM LASER FIBER WAS BEING USED FOR STONE FRAGMENTATION IN THE LOWER CALYX OF THE KIDNEY WHEN THERE WAS A LOSS OF DEFLECTION IN THE FLEXIBLE SCOPE, WHICH MADE IT "IMPOSSIBLE TO FINISH THE PROCEDURE. IT WAS FOUND THAT THE LASER FIBER BROKE INSIDE THE SCOPE, DAMAGING THE DEFLECTION AND INTERNAL COATING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS REPORTED THAT NONE WOULD BE RECEIVED AS THIS EVENT WAS REPORTED TO (B)(6) AND NO CONTACT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707005 ↗
• MalfunctionNov 20, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A LITHOTRIPSY PROCEDURE IN THE KIDNEY, APPROXIMATELY ONE OR TWO MINUTES AFTER SURGEON STARTED USING THE LASER, THE TIP DETACHED FROM THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER. THE DOCTOR WAS ABLE TO REMOVE THE TIP WITH A ZERO TIP BASKET. ONCE THE TIP WAS REMOVED FROM THE KIDNEY, ANOTHER FIBRE WAS USED TO COMPLETE THE CASE. NI ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090244 ↗
• MalfunctionAug 2, 2018Break

  IT WAS REPORTED THAT THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER SNAPPED WHILE LASERING. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744226 ↗
• MalfunctionJul 21, 2017Flaked; Flaked

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, A SMALL AMOUNT OF GLASS FLAKED OFF THE END OF THE FIBER. THE DOCTOR COULD NOT SEE A GLASS PARTICLE AND DID NOT KNOW WHETHER IT WAS VAPORIZED. THEY CONTINUED WITH THE PROCEDURE AND DID NOT REMOVE ANY GLASS PIECES. THERE WERE NO INJURIES TO THE PATIENT AND NO ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731587 ↗
• MalfunctionApr 21, 2016Material Separation; Material Separation

  DURING A BILATERAL URETERO PYELOSCOPY, LASER AND STENT EXCHANGE ON A (B)(6) YEAR OLD MALE PATIENT WITH A NORMAL ANATOMY, THE WIRE SNAPPED IN HALF DURING THE CASE. THE FIBER BROKE IN THE DISTAL PART OF THE SCOPE. THE SCOPE WAS REMOVED FROM WITHIN THE PATIENT AND THE BROKEN FIBER WAS SIMPLY PULLED OUT OF THE SCOPE BY THE SURGEON. ANOTHER WIRE WAS OPENED AND USED. NO PIECE OF DEVICE REMAINED INSIDE PATIENT. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE. NO ADVERSE EFFECT TO PATIENT HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5596028 ↗