NA 6001-088-227Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540245854), received between Mar 10, 2017 and Jan 13, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Incorrect Measurement; Deformation Due to Compressive Stress; Incorrect Measurement; Deformation Due to Compressive Stress

  PER THE CUSTOMER, THE DEVICE WAS BENT WHICH CAN LEAD TO INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158488 ↗
• MalfunctionNov 16, 2021Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BENT AND CAUSED INCORRECT CALIBRATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821501 ↗
• MalfunctionFeb 25, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366555 ↗
• MalfunctionDec 27, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199188 ↗
• MalfunctionOct 3, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS FOUND TO BE BENT AND NON FUNCTIONAL AFTER COLLIDING WITH A DRILL DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931394 ↗
• MalfunctionAug 9, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO HAVE HAD A BROKEN PIECE NEXT TO THE LEDS. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR DELAYS TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7768035 ↗
• MalfunctionMar 10, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LED LENS OF THE DEVICE WAS IDENTIFIED AS BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT AS THE EVENT OCCURRED DURING THE EVALUATION PROCESS.

  Patient problems: No Patient Involvement

  MAUDE report 6394715 ↗