AccuStat 0010-6110Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00878953000121), received between May 3, 2018 and May 26, 2022 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT WHILE TRYING TO TEST FIRE, THE LASER AIMING BEAM WAS VERY HIGH UP AND NOT SHOWING THROUGH THE TIP AS USUAL. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. THE FIBER WAS RETURNED FOR ANALYSIS AND THE TESTING CONDUCTED IDENTIFIED THE FIBER BEING BROKEN, AND THE DISTAL END WAS NOT RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515109 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT DURING PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE THIS FIBER EXHIBITED AN INTERNAL BREAK APPROXIMATELY TWO TO THREE INCHES ABOVE THE HANDPIECE. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429535 ↗
• MalfunctionAug 27, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A BREAK IN THE FIBER, WHERE THE WIRE MEETS THE HANDPIECE. THE BREAK OCCURRED OUTSIDE OF THE PATIENT AFTER 3 JOULES AND 00:05 MINUTES OF USE. THE FIBER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378748 ↗
• MalfunctionJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER WAS RETURNED WITHOUT INFORMATION. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE FIBER TIP WAS BROKEN AND DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 12207199 ↗
• MalfunctionJun 7, 2021Break; Adverse Event Without Identified Device or Use Problem; Firing Problem; Break; Adverse Event Without Identified Device or Use Problem; Firing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN FOUND THE FIBER WAS NOT EMITTING ENERGY AFTER 2 JOULES AND 11 SECONDS OF USE. A BREAK WAS OBSERVED ON THE FIBER BODY AND LOW LEVEL ENERGY WAS OBSERVED TO BE EMITTED FROM THE LOCATION OF THE BREAK. THE FIBER WAS REPLACED AND A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952343 ↗
• MalfunctionMay 6, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE FIBER TIP BROKE OFF. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787741 ↗
• InjuryNov 23, 2020Break; Break

  IT WAS REPORTED THAT DURING STAPEDECTOMY SURGICAL PROCEDURE, THE FIBER TIP BROKE AND STARTED FIRING FROM THE SIDE INSTEAD OF THE TIP, CHARRING (BURN) THE INCUS. THE PHYSICIAN LOOKED UNDER THE MICROSCOPE AND OBSERVED THAT THE FIBER WAS AT ABOUT A 45 DEGREE ANGLE. THE FIBER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND NO INJURY TO THE STAFF. THE PHYSICIAN AND THE STAFF WERE WEARING THE SAFETY GLASSES. IT IS UNKNOWN IF TREATMENT WAS ADMINISTERED TO THE PATIENT DUE TO THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 10886410 ↗
• MalfunctionAug 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE FIBER DIMINISHED POWER AFTER 17 JOULES OF USE. THE TIP OF THE FIBER APPEARED INTACT. THERE WAS NO FIBER BREAKAGE AND NO PIECE OF THE FIBER TIP DETACHED INSIDE THE PATIENTS BODY. THE FIBER WAS REPLACED AND THE PROCEDURE COMPLETED WITH 9 JOULES OF USE. THERE WAS NO PATIENT HARM AS A RESULT OF THE EVENT. THE FIBER WAS RETURNED AND ANALYSIS FOUND THE FIBER CAP TIP WAS FOUND TO BE FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10436983 ↗
• MalfunctionSep 12, 2019Break; Break

  IT WAS REPORTED THAT THE FIBER WAS BROKEN AS SOON AS IT WAS OPENED, AND IT WAS NEVER USED ON A PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9007198 ↗
• MalfunctionApr 5, 2019Fracture; Fracture

  ANALYSIS OF THE DEVICE FOUND THAT THE FIBER WAS FRACTURED WITHIN THE CLEAR TUBING AT THE TIP END OF THE FIBER. PATIENT OUTCOME INFORMATION WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8489438 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER TIP WAS BROKEN UPON OPENING. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT AND USER COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711296 ↗
• MalfunctionJul 18, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE FIBER WAS ALREADY BENT AND BROKEN UPON OPENING. THE FIBER WAS EXCHANGED AND THE SAME ISSUE OCCURRED WITH THE SECOND FIBER. THE SECOND FIBER WAS REPLACED AND THE CASE WAS COMPLETED WITH A THIRD FIBER. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. THIS REPORT IS FOR THE SECOND FIBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697995 ↗
• MalfunctionJul 18, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE FIBER WAS ALREADY BENT AND BROKEN UPON OPENING. THE FIBER WAS EXCHANGED AND THE SAME ISSUE OCCURRED WITH THE SECOND FIBER. THE SECOND FIBER WAS REPLACED AND THE CASE WAS COMPLETED WITH A THIRD FIBER. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. THIS REPORT IS FOR THE FIRST FIBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7697973 ↗
• MalfunctionMay 3, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE FIBER DID NOT WORK. THE FIBER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED UTILIZING A SECOND FIBER. PATIENT OUTCOME: NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482875 ↗