CORE 5402007000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327423631), received between May 29, 2020 and Apr 11, 2025 — classified as 7 malfunctions.

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

• MalfunctionApr 11, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED RUN ON DURING A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826184 ↗
• MalfunctionApr 11, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED RUN ON DURING A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825892 ↗
• MalfunctionJan 25, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WAS RUNNING ON DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239533 ↗
• MalfunctionJan 12, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED RUN ON DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150420 ↗
• MalfunctionApr 11, 2022Unintended Power Up; Unintended Power Up

  DURING TESTING AT THE USER FACILITY IT WAS REPORTED THAT THE PEDAL ACTIVATED THE DRILL WHILE NOT INTENDING TO DO SO. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075343 ↗
• MalfunctionJul 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE WAS STICKING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 10329720 ↗
• MalfunctionMay 29, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FOOT PEDAL WAS STICKING DURING TESTING AT THE USER FACILITY, A CONDITION WHICH COULD RESULT IN UNINTENDED ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10100987 ↗