Slimline EZ 550 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290109140186), received between Jan 19, 2020 and Nov 26, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, DURING PREPARATION OF THE PROCEDURE, THIS FIBER COULD NOT BE USED. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789715 ↗
• MalfunctionOct 3, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING TRANSURETHRAL LASER ENUCLEATION OF THE PROSTATE PREPARATIONS, THE BLACK AND GREEN JUNCTION OF THE FIBER INTERFACE EMITTED SPARK, AND IT WAS NOT USED ON THE PATIENT. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS RECEIVED, AND THE ANALYSIS CONFIRMED THERE WAS AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364440 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE THE FIBER WAS FRACTURED WHEN FIRED DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS STABLE, THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950430 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF PROSTATE PROCEDURE, THE FIBER BROKE AND THE LASER PUNCTURED THE HEEL OF THE PHYSICIAN. THE HEEL INJURY WAS TREATED WITH ALCOHOL TO DISINFECT AND A BANDAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 19489428 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SIDE PERCUTANEOUS NEPHROLITHOTRIPSIS (PCNL) PROCEDURE, WHERE IT WAS NOTED THAT THE STONE TO TREAT WAS MUCH LARGER THAN EXPECTED. THEREFORE, IT WAS USED PNEUMATIC BALLISTIC LITHOTRIPSY AND HOLMIUM LASER TO REDUCE THE SIZE OF THE STONES INTO FRAGMENTS. AT THE MOMENT THE NURSE INSTALLED THE FIBER IT WAS FOUND TO BE FRACTURED. DUE TO THIS, THE FIBER WAS NOT USED AND ONLY LITHOTRIPSY WAS USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779003 ↗
• MalfunctionAug 23, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE FIBER BURST WHEN THE PEDAL WAS PRESSED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608589 ↗
• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT DURING A TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, WHEN THE PEDAL IS STEPPED, THE FIBER BURST DIRECTLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592660 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT AFTER THE FIBER WAS CONNECTED, IT BROKE WHEN THE PHYSICIAN STEPPED ON THE PEDAL. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628668 ↗
• MalfunctionJan 19, 2020Failure to Deliver Energy; Fracture; Failure to Deliver Energy; Fracture

  A FOREIGN USER FACILITY REPORTED THAT AT THE START OF A PROCEDURE IN WHICH A SLIMLINE EZ 200 DISPOSABLE FIBER WAS BEING UTILIZED WITH A VPPS 60W LASER, THE FIBER WOULD NOT FIRE. FOLLOWING EVALUATION IT WAS FOUND THAT THE FIBER "DID NOT GUIDE THE LIGHT" AND WAS BROKEN. THE PROCEDURE WAS SUBSEQUENTLY CANCELLED AND THE PATIENT WAS AWAKENED FROM ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604849 ↗