Optilite G48526Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002485266), received between Jun 28, 2016 and Aug 3, 2018 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2018Break

  THE COMPLAINANT REPORTED THAT DURING A LASER LITHOTRIPSY, THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER BROKE BETWEEN THE HUB AND THE SCOPE AFTER APPROXIMATELY ONE MINUTE OF LASING AT 6 W. THE PRODUCT PROBLEM DID NOT RESULT IN ANY SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747582 ↗
• MalfunctionAug 3, 2018Break

  THE COMPLAINANT REPORTED THAT THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER BROKE INSIDE THE SCOPE UPON FIRING IT FOR THE FIRST TIME. IT WAS FURTHER NOTED THAT THE BROKEN LASER FIBER DAMAGED THE SCOPE RENDERING IT "USELESS". THE TOTAL ENERGY USED DURING THE PROCEDURE WAS 6.4 JOULES. A NEW FIBER WAS OPENED AND USED TO COMPLETE THE URETEROSCOPY WITH A NEW SCOPE. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7747034 ↗
• MalfunctionAug 2, 2018Break

  THE COMPLAINANT REPORTED THAT THE PATIENT UNDERWENT A RIGHT URETEROSCOPY AND LASER LITHOTRIPSY. THE LASER SETTINGS WERE 0.8 J (JOULES), 8 PULSE/SECONDS WITH A TOTAL ENERGY OF 0.88KJ (KILOJOULES). THE OPTILITE SINGLE-USE HOLMIUM LASER FIBER BROKE, AND ONCE IT BROKE, THE PHYSICIAN STOPPED FIRING THE LASER AND REMOVED THE FIBER IMMEDIATELY. ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE, AND THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7743011 ↗
• InjuryNov 9, 2016Material Separation; Material Separation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 6089909 ↗
• InjuryJun 28, 2016Material Separation; Material Separation

  WHILE PERFORMING A URETERAL CALCULI PROCEDURE ON A PATIENT, THE FIBER BROKE INSIDE THE KIDNEY. THE PHYSICIAN PLANS TO HAVE THE PATIENT RETURN FOR REMOVAL OF ADDITIONAL STONES. THE FIBER'S LOCATIONS IS UNKNOWN AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5756575 ↗