SureFlex 200 S-LLF200TGRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00878953004822), received between Dec 19, 2017 and Oct 8, 2020 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE PHYSICIAN WAS HOLDING THE FIBER WITH TWO FINGERS, WHEN THE FIBER RUPTURED CAUSING A HAND WOUND. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER.

  Patient problems: Tissue Damage

  MAUDE report 10652750 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED THAT THE FIBER WAS BROKEN REACHING THE LOWER POLE STONE IN THE KIDNEY. THE METHOD USED TO COMPLETE THE PROCEDURE AND PATIENT OUTCOME WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759400 ↗
• InjuryAug 29, 2019Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE DURING USE CAUSING A WELT OR BURN ON THE SURGEONS RIGHT INDEX FINGER. THE GLOVES WERE REMOVED AND BETADINE AND A BANDAID APPLIED. THE SURGEON PUT ON NEW GLOVES AND THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AND THE SURGEON REQUIRED NO ADDITIONAL TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 8945698 ↗
• MalfunctionApr 5, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ANALYSIS OF THE DEVICE FOUND THAT THE FIBER WAS BROKEN AND DETACHED. THERE WAS NO PATIENT OUTCOME INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8489415 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE LASER FIBER SNAPPED OUTSIDE OF THE URETER SCOPE WHILE IN USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO PATIENT OR USER CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260861 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE FIBER BURNT THE STAFF MEMBERS HAND. USER OUTCOME IN RESPONSE TO THE REPORTED EVENT WAS NOT PROVIDED AND IT WAS INDICATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 8189112 ↗
• MalfunctionDec 13, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THE FIBER BROKEN INTO TWO PIECES. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162336 ↗
• MalfunctionDec 5, 2018Break; Break

  ANALYSIS OF THE RETURN DEVICE REVEALED THAT THE DISTAL TIP OF THE FIBER IS FRACTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8134251 ↗
• MalfunctionDec 3, 2018Break; Break

  DURING A LASER LITHOTRIPSY PROCEDURE THE FIBER BROKE AT THE DISTAL END OF THE RIGID URETEROSCOPE. THE LASER WAS STOPPED. THE FIBER WAS RETRIEVED FROM INSIDE THE PATIENT. THERE IS NO REPORT OF INJURY TO THE PATIENT OR HOW THE CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125458 ↗
• MalfunctionOct 8, 2018Smoking; Smoking

  IT WAS REPORTED THAT DURING THE PROCEDURE AFTER PLUGGING THE FIBER INTO THE CONSOLE, THE CONNECTOR OVERHEATED, BEGAN SMOKING, AND ONCE REMOVED FELL OFF. A SECOND FIBER WAS CONNECTED TO THE CONSOLE AND THE CONNECTOR OVERHEATED. THE FIBER WAS REMOVED AND A THIRD FIBER WAS PLUGGED INTO THE CONSOLE. THE CASE WAS COMPLETED WITHOUT INJURY TO THE PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945497 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED THAT DURING LASER EMISSION, THE FIBER BROKE IN THE PATIENT'S URETER. NO PATIENT OUTCOME WAS PROVIDED DUE TO THE REPORTED EVENT, AND IT IS UNKNOWN IF THE CASE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7842488 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE SPONTANEOUSLY IN THE FLEXIBLE URETEROSCOPE IN SUCH A WAY THAT THERE WAS NO OUTPUT BEAM. NO INFORMATION WAS PROVIDED AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7760089 ↗
• MalfunctionJul 27, 2018Break; Fracture; Break; Fracture

  ANALYSIS OF THE RETURN DEVICE REVEALED THAT THE FIBER IS BROKEN WITHIN THE FIBER BLUE OUTER SHEATH, A FRACTURE ON THE DISTAL TIP OF THE FIBER, AND A DETACHMENT OF THE FIBER 9.5 INCHES FROM THE DISTAL TIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728405 ↗
• MalfunctionJul 3, 2018Fracture; Fracture

  IT WAS REPORTED THAT UPON ACTIVATION OF THE SURGICAL FIBER DURING A STONE PROCEDURE, THE FIBER BROKE OUTSIDE THE SCOPE NEAR THE PHYSICIAN. THE OUTPUT BEAM WAS REPORTED TO HAVE HIT THE SURGEON IN THE CHEST AREA OF HIS LEAD GOWN BUT NO PERFORATION WAS NOTED. THE FIBER WAS REPLACED AND THE PROCEDURE CONTINUED USING A SECOND SURGICAL FIBER, WHICH WAS REPORTED TO HAVE BROKEN UPON ACTIVATION INSIDE OF THE SCOPE. NO PATIENT OR STAFF INJURY WAS REPORTED. THIS EVENT IS FOR THE FIRST SURGICAL FIBER USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660505 ↗
• MalfunctionJul 3, 2018Fracture; Fracture

  IT WAS REPORTED THAT UPON ACTIVATION OF THE SURGICAL FIBER DURING A STONE PROCEDURE, THE FIBER BROKE OUTSIDE THE SCOPE NEAR THE PHYSICIAN. THE OUTPUT BEAM WAS REPORTED TO HAVE HIT THE SURGEON IN THE CHEST AREA OF HIS LEAD GOWN BUT NO PERFORATION WAS NOTED. THE FIBER WAS REPLACED AND THE PROCEDURE CONTINUED USING A SECOND SURGICAL FIBER, WHICH WAS REPORTED TO HAVE BROKEN UPON ACTIVATION INSIDE OF THE SCOPE. NO PATIENT OR STAFF INJURY WAS REPORTED. THIS EVENT IS FOR THE SECOND SURGICAL FIBER USED.

  Patient problems: Injury

  MAUDE report 7660501 ↗
• MalfunctionMar 8, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE FIBER BROKE WHILE EXITING THE URETEROSCOPE. THE FIBER WAS EXCHANGED AND THE SECOND FIBER BROKE IN THE HANDS OF THE NURSE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THE HAND OF THE NURSE WAS REPORTED TO BE "LIGHTLY BRUISED", NO SUBSEQUENT TREATMENT OR MEDICAL INTERVENTION WAS REPORTED. NO HARM TO THE PATIENT REPORTED. THIS REPORT IS FOR THE FIRST FIBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323948 ↗
• MalfunctionJan 24, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING URETEROSCOPY PROCEDURE; FIBER WAS OBSERVED TO BE BROKEN OUT FROM THE PACKAGE WHEN OPENING DURING THE CASE WAS NOTED. ADDITIONALLY IT WAS REPORTED THAT THE FIBER WAS NEVER USED. THE PROCEDURE WAS COMPLETED USING SECOND FIBER. PATIENT OUTCOME: NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217331 ↗
• MalfunctionDec 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE USING TWO SUREFLEX FIBERS DURING A PROCEDURE, THE FIBER ENDS BROKE OFF. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY REPORTED. THIS EVENT IS FOR THE FIRST SURGICAL FIBER USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131783 ↗
• MalfunctionDec 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE USING TWO SUREFLEX FIBERS DURING A PROCEDURE, THE FIBER ENDS BROKE OFF. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY REPORTED. THIS EVENT IS FOR THE SECOND SURGICAL FIBER USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131753 ↗