NA 6001-022-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540245809), received between Feb 16, 2017 and Sep 25, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Incorrect Measurement; Deformation Due to Compressive Stress; Material Twisted/Bent; Incorrect Measurement; Deformation Due to Compressive Stress; Material Twisted/Bent

  PER THE CUSTOMER, THE DEVICE BENT DURING THE CASE WHICH CAN LEAD TO INACCURACIES. 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 17806399 ↗
• MalfunctionMay 22, 2023Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement; Material Twisted/Bent

  PER THE CUSTOMER, THE DEVICE BENT DURING THE CASE WHICH CAN LEAD TO INACCURACIES. 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 16980254 ↗
• MalfunctionMar 20, 2023Incorrect Measurement; Incorrect Measurement

  PER THE SALES REP, THE TIP WAS BENT DURING A CASE WHICH COULD CAUSE INACCURACIES. 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 16577372 ↗
• MalfunctionJan 13, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  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 16156868 ↗
• MalfunctionJun 27, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  PER THE CUSTOMER, THERE WAS A LOSS OF ACCURACY DURING THE IMAGE GUIDED PROCEDURE. 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 14827707 ↗
• MalfunctionSep 29, 2020Imprecision; Material Deformation; Imprecision; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE TIP WAS BENT AFTER VALIDATION. 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 10600999 ↗
• MalfunctionOct 2, 2018Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY; THE DEVICE'S TIP WAS FOUND TO BE BROKEN. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925719 ↗
• MalfunctionFeb 16, 2017Disassembly; Disassembly

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

  Patient problems: No Patient Involvement

  MAUDE report 6335147 ↗