NA 03.010.494Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982069115), received between Aug 25, 2025 and Mar 24, 2026 — classified as 7 malfunctions.

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

• MalfunctionMar 24, 2026Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT THE HOOK AT THE END OF THE DEPTH GAUGES WAS SO BENT IT WAS NO LONGER ABLE TO CATCH THE FAR CORTEX TO PROVIDE AN ACCURATE MEASUREMENT. THERE WAS NO REPORTED PATIENT OR USER HARM WITH NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672911 ↗
• MalfunctionMar 24, 2026Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT THE HOOK AT THE END OF THE DEPTH GAUGES WAS SO BENT IT WAS NO LONGER ABLE TO CATCH THE FAR CORTEX TO PROVIDE AN ACCURATE MEASUREMENT. THERE WAS NO REPORTED PATIENT OR USER HARM WITH NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672910 ↗
• MalfunctionMar 18, 2026Material Deformation; Material Integrity Problem

  DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE SMALL METAL HOOK AT THE TIP OF THE DEPTH GAUGE WAS DAMAGED AND BENT. THIS ITEM WAS THEN DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626198 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE MEASURING DEVICES ARE BEND AND NOT ABLE TO BE ASSEMBLED. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890606 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE MEASURING DEVICES ARE BEND AND NOT ABLE TO BE ASSEMBLED. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890604 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE MEASURING DEVICES ARE BEND AND NOT ABLE TO BE ASSEMBLED. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890487 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE MEASURING DEVICES ARE BEND AND NOT ABLE TO BE ASSEMBLED. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890484 ↗