8000229Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816469021315), received between Jan 24, 2023 and Aug 7, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Break

  A LASER FIBER WIRE BROKE OFF INSIDE OF THE PATIENT'S RIGHT KIDNEY. AFTER SPEAKING WITH THE SURGEON ABOUT IT, HE FELT THAT NO OTHER INTERVENTION WAS NECESSARY INCLUDING AN XRAY. HE SAID THE REASON HE FELT AN X-RAY WAS UNNECESSARY WAS BECAUSE "LASER FIBER TIPS ARE NON DETECTABLE THROUGH X-RAY". SURGEON ALSO STATED THAT AFTER LOOKING IN THE PATIENT'S URETER AND KIDNEY THAT THE FIBER WAS UNDETECTABLE AND "DID NOT SEE IT IN ORDER TO RETRIEVE IT". UPON FURTHER CONVERSATION, SURGEON DID STATE THAT HE WOULD "INFORM THE PATIENT OF WHAT HAPPENED" REGARDING THE FIBER WIRE TIP. THIS IS NOT THE FIRST TIME LASER FIBER WIRE TIPS OF THIS PARTICULAR BRAND AND BATCH HAVE BROKEN OFF DURING SURGICAL PROCEDURES. TIP OF THE FIBER WHILE IT WAS INSERTED THROUGH THE SCOPE. TIP OF THE FIBER BROKE WHILE RUNNING UP THE SCOPE. THE FIBER WAS STILL USEABLE. SETTINGS: ENERGY: 0.3J, FREQUENCY: 50HZ, POWER: 24W.

  Patient problems: Foreign Body In Patient

  MAUDE report 22737162 ↗
• MalfunctionMay 7, 2025Break; Material Disintegration

  AT 0840 IT WAS TIME FOR LASER LITHOTRIPSY AND THE LASER REP, PASSED OFF THE AGILITI 272U LASER FIBER PL WITH LOT# DB25006. THE LASER FIBER BROKE, TWO PIECES BROKE OFF INSIDE THE PATIENT, TWO BROKEN PIECES WERE RETRIEVED AND BAGGED. A SECOND LASER FIBER, AGILITI 272U LASER FIBER PL ALSO WITH LOT# DB25006 WAS OPENED AND PASSED TO SURGEON. THE SECOND LASER FIBER BROKE, ONE PIECE BROKE OFF IN THE PATIENT, ONE PIECE WAS RETRIEVED AND BAGGED. A THIRD LASER FIBER, AGILITI 272U LASER FIBER PL WITH NEW LOT# DB25017 WAS OPENED AND PASSED TO SURGEON. THE THIRD LASER FIBER BROKE, ONE PIECE BROKE OFF IN THE PATIENT, ONE PIECE WAS RETRIEVED AND BAGGED. LASER SERVICES WERE DISCONTINUED. ALL FIBERS AND BROKEN PIECES WERE BAGGED AND LABLED. SURGEON REQUESTED DIFFERENT LASER MACHINE TO BE BROUGHT IN. STENT WAS PLACED AND PATIENT PROCEDURE CONCLUDED. AGILITI LASER REP, PUT IN AN INCIDENT REPORT WITH HIS COMPANY WHICH WAS TO BE SENT TO OR MANAGER.

  Patient problems: Foreign Body In Patient

  MAUDE report 21976055 ↗
• MalfunctionJun 16, 2023Material Too Soft/Flexible

  MD NOTICED THAT THE FIBER WIRE WAS WEAK AND WAS GOING TO BREAK IF USED. IF THE FIBER WIRE HAD BEEN USED THERE WAS POTENTIAL THAT THE FIBER COULD HAVE BROKEN OFF INSIDE THE PATIENT. MD OPENED A NEW FIBER WIRE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142558 ↗
• MalfunctionJan 24, 2023Break

  ONE FIBER BROKE AND WORE OUT FASTER THAN EXPECTED. CONTINUED TO OPEN ANOTHER FIBER THAT WORKED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232205 ↗