Slimline EZ 200 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07290109140162), received between Oct 25, 2022 and Nov 13, 2024 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE FIBER WAS CONNECTED AND FIRED DURING THE PREPARATION FOR LITHOTRIPSY; HOWEVER, THERE WAS NO RESPONSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. UPON RECEIPT OF THE FIBER, THE PRODUCT INVESTIGATION CONFIRMED THE CONNECTOR WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679330 ↗
• MalfunctionJul 16, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER HAD NO ENERGY OUTPUT AND WAS FOUND TO BE BLACK WHEN USING A LIGHT METER. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURED CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750494 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PATIENT'S RIGHT URETERAL SOFT LENS LASER LITHOTRIPSY, THE FIBER WAS FRACTURED AT THE ENTRANCE OF THE SOFT LENS WORKING CHANNEL. THE FIBER WAS IMMEDIATELY REPLACED WITH A NEW FIBER TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274340 ↗
• MalfunctionMay 7, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A URETERAL LITHOTRIPSY, IT WAS IDENTIFIED THAT THERE WAS NO ENERGY OUTPUT WHEN USING THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. AFTER THE FIBER WAS ANALYZED, IT WAS FOUND AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265488 ↗
• MalfunctionFeb 15, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER DID NOT PROPERLY OUTPUT ENERGY. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH THE OTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A BREAK IN THE FIBER BODY AND IN THE FIBER CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715207 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT THE FIBER TIP WAS FRACTURED JUST AFTER IT WAS PUT INTO OPERATION. THE FIBER TIP WAS REMOVED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558340 ↗
• MalfunctionOct 18, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER WAS USED FOR THE FIRST TIME. AFTER APPROXIMATELY ONE TO TWO MINUTES OF USE, THERE WAS NO LONGER ANY OUTPUT FROM THE FIBER. IT WAS NOTED THERE WERE NO ERROR MESSAGES RECEIVED. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING THE SECOND FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER BREAK WITHIN THE FIBER CONNECTOR. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER BREAK WITHIN THE FIBER CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959232 ↗
• MalfunctionOct 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING INTRODUCTION OF THE FIBER INSIDE THE PATIENT, THE METAL TIP OF THE FIBER WAS OVERHEATING. THERE WERE NO PATIENT COMPLICATIONS. NO INFORMATION WAS AVAILABLE REGARDING THE PROCEDURE'S OUTCOME. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER FRACTURE WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916293 ↗
• MalfunctionSep 11, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A TRANSURETHRAL URETEROSCOPE LASER LITHOTRIPSY PROCEDURE, IT WAS FOUND THAT THE FIBER DID NOT WORK WHEN IT WAS INSERTED. THE FIBER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A SPARE FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719199 ↗
• MalfunctionAug 10, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING FIRST USE OF THIS FIBER, BLACK SPOTS WERE IDENTIFIED DURING TESTING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ANALYSIS OF THE FIBER IDENTIFIED A FIBER INTERNAL CONNECTOR FRACTURE AND A FIBER BODY KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502948 ↗
• MalfunctionJul 10, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, UPON CHECKING THIS FIBER DURING FIRST USE, BLACK SPOTS WERE IDENTIFIED. THE FIBER WAS STERILIZED WITH ETHYLENE OXIDE. DURING SET-UP THE CONNECTOR FACE WAS WIPED CLEAN. THE PROCEDURE WAS COMPLETED WITH THE SAME FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288874 ↗
• MalfunctionJun 7, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT THE FIBER WAS CONNECTED TO THE HOLMIUM LASER BUT THERE WAS NO ENERGY EMISSION. THE FIBER WAS REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. AFTER THAT, THE PRODUCT WAS RETURNED FOR ANALYSIS, AND IT CONCLUDED THAT THERE WAS AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084061 ↗
• MalfunctionApr 18, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE WITH THIS SLIMLINE FIBER, NO ENERGY WAS PRESENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766258 ↗
• MalfunctionMar 1, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED UPON UNPACKING. PROCEDURE WAS NO COMPLETED DUE TO THIS EVENT. PATIENT WAS STABLE UNDER GENERAL ANESTHESIA, THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463990 ↗
• MalfunctionFeb 15, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING PROCEDURE, THE FIBER CONNECTOR WAS BROKEN AND THERE WAS NO OUTPUT ENERGY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378407 ↗
• MalfunctionDec 16, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SOFT URETEROSCOPY LITHOTRIPSY, THE FIBER BROKE INSIDE THE PATIENT. DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995873 ↗
• MalfunctionDec 2, 2022Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE WITH A PATIENT UNDER SEDATION, THE FIBER FRACTURED. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. IT WAS NOTED THAT THE FIBER FRACTURE WAS DUE TO IMPROPER OPERATION BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904465 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE FIBER BROKE. THE PHYSICIAN REMOVED THE FOREIGN BODY CLAMP AND CHECKED THE INTEGRITY OF THE FIBER. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15856990 ↗
• MalfunctionOct 25, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT WHEN THE FIBER WAS LOOKED UNDER THE FIBER INSPECTION SCOPE, THE GLASS TIP WAS BROKEN AND HAD BLACK SPOTS, THIS FIBER COULD NOT BE USED AGAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671186 ↗