n.a. 27026EFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551231876), received between Oct 10, 2019 and Mar 13, 2026 — classified as 2 injuries, 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. 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.

• MalfunctionMar 13, 2026Material Separation

  IT WAS REPORTED THAT THE END OF THE DEFLECTING MECHANISM HAD BEEN BROKEN AND WAS FOUND TO BE MISSING. THE CUSTOMER WAS INFORMED OF THIS AND IS TRYING TO PROVIDE FURTHER INFORMATION ON THE WHEREABOUTS OF THE MISSING PART. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24592372 ↗
• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT "A BILATERAL URETEROSCOPY PROCEDURE WAS DONE. DURING THE PRE-DISINFECTION OF THE INSTRUMENTS, IT WAS NOTED THAT THE TIP OF THE ALBARRAN LEVER WAS MISSING, EVEN THOUGH IT IS NON-REMOVABLE. AFTER SEARCHING FOR THE TIP INSIDE THE PATIENT USING FLUOROSCOPY, IT WAS LOCATED WITHIN THE PATIENT. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM THE SAME EVENING FOR REMOVAL OF THE TIP, BUT IN A DIFFERENT SURGICAL SUITE".

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470841 ↗
• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT "A BILATERAL URETEROSCOPY PROCEDURE WAS DONE. DURING THE PRE-DISINFECTION OF THE INSTRUMENTS, IT WAS NOTED THAT THE TIP OF THE ALBARRAN LEVER WAS MISSING, EVEN THOUGH IT IS NON-REMOVABLE. AFTER SEARCHING FOR THE TIP INSIDE THE PATIENT USING FLUOROSCOPY, IT WAS LOCATED WITHIN THE PATIENT. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM THE SAME EVENING FOR REMOVAL OF THE TIP, BUT IN A DIFFERENT SURGICAL SUITE".

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470840 ↗
• MalfunctionNov 26, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE END OF THE DEVICE, WHICH WAS ROTATABLE, BROKE OFF IN THE PATIENT'S BLADDER AND WAS ONLY NOTICED WHEN ANOTHER ENDOSCOPE WAS INSERTED. THIS PROLONGED THE OPERATION AS THE SURGEON HAD TO TRY TO FISH OUT THE FOREIGN BODY AND THE PATIENT'S BLADDER. THE USER'S REPORT TO THE LOCAL AUTHORITY ALSO INDICATES, ON THE BASIS OF THE SELECTED IMDRF CODES, THAT THERE WAS A URINARY TRACT INFECTION AND AN UNSPECIFIED KIDNEY OR URINARY PROBLEM. NO DETAILED INFORMATION IS AVAILABLE ON THIS.

  Patient problems: Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 20789058 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER MANUFACTURER INCIDENT REPORT (B)(4) RECEIVED FROM THE FACTORY IN GERMANY:IT WAS REPORTED THAT THE DISTAL END OF THE CATHETER DEFLECTING MECHANISM BROKE OFF DURING THE PROCEDURE. THE BROKEN OFF PART HAS NOT BEEN FOUND AND AN X-RAY WAS TAKEN WITHOUT DETECTING THE MISSING PART IN THE PATIENT. THE BROKEN OFF PART COULD HAVE REMAINED IN THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653495 ↗
• MalfunctionOct 10, 2019Material Separation; Material Separation

  ALLEGEDLY PER THE CUSTOMER, DURING A CYSTOSCOPY WITH BIOPSY THE TIP OF THE DEFLECTOR MECHANISM BROKE OFF WHILE INSIDE THE PATIENT. THE TIP WAS RETRIEVED IN ONE PIECE WITH NO HARM TO THE PATIENT. ONCE THE PIECE WAS RETRIEVED THE PROCEDURE CONTINUED AND COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176615 ↗