SureFlex 273 S-LLF273TGRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00878953004839), received between Nov 29, 2017 and Apr 4, 2025 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT, DURING LITHOTRIPSY PROCEDURE, THE FIBER BROKE INSIDE THE PATIENT. IT WAS NOTED THAT A PIECE WAS STUCK IN THE PATIENT AND THAT THE FIBER BREAK CAUSED DAMAGE TO SCOPE USED AS WELL. NO FURTHER INFORMATION PROVIDED ON THE PROCEDURE OUTCOME. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777875 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT, PRIOR TO LITHOTRIPSY PROCEDURE, THE FIBER BROKE ABOUT FOUR INCHES FROM THE LASER CONSOLE. NO FURTHER INFORMATION PROVIDED ON PROCEDURE OUTCOME. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777874 ↗
• InjuryDec 17, 2024Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE DURING USE ON A PATIENT. IT SNAPPED APPROXIMATELY 4 INCHES ABOVE THE SURGEON'S HAND, RESULTING IN A BURN FROM THE LASER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Burn(s)

  MAUDE report 20957178 ↗
• MalfunctionNov 7, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE THE SUREFLEX FIBER WAS DEFECTIVE AFTER A HALF MINUTE AT 5W 5HZ . THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT. PROCEDURE WAS COMPLETED WITH ANOTHER FIBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292303 ↗
• MalfunctionOct 30, 2019Fracture; Fracture

  THE FIBER WAS RECEIVED WITHOUT INFORMATION. ANALYSIS OF THE DEVICE FOUND THAT THE FIBER DISTAL TIP WAS FRACTURED. THERE WAS NO PATIENT OUTCOME INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9258062 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT THE FIBER WAS NOTICED TO BE BROKEN INSIDE OF THE SCOPE DURING A URS PROCEDURE TO REMOVE A STONE IN THE KIDNEY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER OF THE SAME DEVICE. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219430 ↗
• MalfunctionOct 21, 2019Fracture; Fracture

  ANALYSIS OF THE DEVICE FOUND THE FIBER TIP TO BE FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214094 ↗
• InjuryApr 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A FLEXIBLE URETEROSCOPY SURGERY WITH THE DESTRUCTION OF A CALCULUS BY LASER, THE FIBER BROKE AFTER 5 MINUTES OF GRINDING IN THE PALM OF THE NURSE WHO WAS HOLDING THE FIBER WITH A COMPRESS. THE STERILE GLOVES AS WELL AS THE BLOUSE WERE PERFORATED BY THE FIBER AND PRESENCE OF A POINT OF BURNING IN THE PALM OF HAND OF THE NURSE WAS NOTICED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR HOW THE CASE WAS COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 8522465 ↗
• MalfunctionApr 10, 2019Break; Break

  ANALYSIS OF THE DEVICE FOUND THAT THE FIBER IS BROKEN WITHIN THE FIBER BLUE JACKET AND BENT AT 5 MM FROM DISTAL TIP. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501772 ↗
• MalfunctionNov 30, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE "LMA" WAS FOUND TO BE DETACHED. THE FIBER WAS NOT USED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT OUTCOME INFORMATION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8120318 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE. PROCEDURE OR PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104682 ↗
• InjuryOct 30, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE FIBER BROKE IN TWO. THE OPERATOR'S RIGHT ARM WAS BURNED AND A BANDAGE WITH BIAFINE WAS ADMINISTERED IN RESPONSE TO THE EVENT. NO HARM TO THE PATIENT REPORTED.

  Patient problems: Burn(s)

  MAUDE report 8020833 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED THAT FROM THE BEGINNING OF A URETEROSCOPY PROCEDURE, THE PHYSICIAN REALIZED THAT THE FIBER HAD BROKEN INSIDE THE FLEXIBLE URETEROSCOPE (UNKNOWN MANUFACTURER). THE URETEROSCOPE WAS NOTED TO HAVE BEEN DAMAGED FOLLOWING PERFORATION OF THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871451 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE FIBER "BROKE SPONTANEOUSLY IN FULL INTERVENTION". IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY REPORTED DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7758194 ↗
• MalfunctionJul 27, 2018Break; Break

  ANALYSIS OF THE RETURN DEVICE REVEALED THAT THE FIBER IS BROKEN WITHIN THE FIBER BLUE OUTER SHEATH AND A DETACHMENT OF THE FIBER 8 FEET AND 6 INCHES FROM THE DISTAL TIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728465 ↗
• InjuryJul 3, 2018Fracture; Fracture

  IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A STONE PROCEDURE, THE FIBER BROKE OUTSIDE THE SCOPE AND THE OUTPUT BEAM HIT THE SURGEON IN THE CHEST. THERE WAS NO DAMAGE TO THE SURGEON'S GOWN SCRUBS. THE FIBER WAS REPLACED AND THE PROCEDURE CONTINUED UNTIL THE FIBER AGAIN BROKE OUTSIDE THE SCOPE, CLOSE TO THE SURGEON. THE OUTPUT BEAM WAS REPORTED TO HIT THE SURGEON ON SLEEVE, LEAVING A SMALL HOLE IN HIS GOWN. THE SURGEON LATER REPORTED BRUISING TO THE MOBILE PROVIDER DURING A FOLLOW UP BUT HAS PROVIDED NO ADDITIONAL INFORMATION. THERE WAS NO PATIENT INJURY REPORTED. THIS EVENT IS FOR THE FIRST SURGICAL FIBER USED.

  Patient problems: Hematoma

  MAUDE report 7659841 ↗
• InjuryJul 3, 2018Fracture; Fracture

  IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A STONE PROCEDURE, THE FIBER BROKE OUTSIDE THE SCOPE AND THE OUTPUT BEAM HIT THE SURGEON IN THE CHEST. THERE WAS NO DAMAGE TO THE SURGEON'S GOWN SCRUBS. THE FIBER WAS REPLACED AND THE PROCEDURE CONTINUED UNTIL THE FIBER AGAIN BROKE OUTSIDE THE SCOPE, CLOSE TO THE SURGEON. THE OUTPUT BEAM WAS REPORTED TO HIT THE SURGEON ON SLEEVE, LEAVING A SMALL HOLE IN HIS GOWN. THE SURGEON LATER REPORTED BRUISING TO THE MOBILE PROVIDER DURING A FOLLOW UP BUT HAS PROVIDED NO ADDITIONAL INFORMATION. THERE WAS NO PATIENT INJURY REPORTED. THIS EVENT IS FOR THE FIRST SURGICAL FIBER USED.

  Patient problems: Hematoma

  MAUDE report 7659840 ↗
• 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 7324043 ↗
• MalfunctionJan 20, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO FIBERS WERE BROKEN 2CM FROM THE EXIT OF THE OPERATING CANAL. THE METHOD USED TO COMPLETE THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT 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 7208662 ↗
• MalfunctionJan 20, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO FIBERS WERE BROKEN 2CM FROM THE EXIT OF THE OPERATING CANAL. THE METHOD USED TO COMPLETE THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT 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 7208660 ↗
• MalfunctionDec 12, 2017Fracture; Fracture

  IT WAS REPORTED THAT TIP DETERIORATION WAS OBSERVED WHILE USING TWO SUREFLEX SURGICAL FIBERS DURING A PROCEDURE; THE METHOD USED TO COMPLETE THE PROCEDURE WAS NOT REPORTED. THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE SECOND SURGICAL FIBER USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7110931 ↗
• MalfunctionDec 11, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE SURGICAL FIBER BROKE INSIDE THE PATIENT DURING THE PROCEDURE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT. THE PHYSICIAN ATTEMPTED TO USE A DIFFERENT MODEL OF THE DEVICE BUT FOUND THAT IT WAS BROKEN WHILE REMOVING IT FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED UTILIZING A THIRD FIBER WITHOUT ISSUE. THIS EVENT IS FOR THE FIRST SURGICAL FIBER USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106632 ↗
• MalfunctionNov 29, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOTED THAT THE FIBER BROKE AT THE ENTRANCE OF THE URETEROSCOPE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: NO REPORT OF INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7068185 ↗