CORE 5400052000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327298505), received between Apr 15, 2019 and Jun 26, 2025 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (18 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRAUMA ADD-ON CASE FROM THE EMERGENCY ROOM, THE CONSOLE WOULD NOT WORK. THE USER FACILITY DID NOT HAVE BACKUP EQUIPMENT. THE TRAUMA PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY AFTER THE PATIENT WAS TRANSFERRED TO A SISTER FACILITY. NO ADDITIONAL MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED. IT IS REPORTED THAT THE PATIENT IS DOING FINE. THIS REPORT IS BEING SUBMITTED DUE TO THE NEED TO TRANSFER THE PATIENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336526 ↗
• MalfunctionJan 23, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217586 ↗
• MalfunctionJan 23, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217450 ↗
• MalfunctionDec 19, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A CASE AT THE USER FACILITY, THE CONSOLE HAD UNINTENDED ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976537 ↗
• MalfunctionJun 6, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE EQUIPMENT KEPT RUNNING DURING SET UP FOR A PROCEDURE. MULTIPLE CORDS AND HANDPIECES WERE TESTED. THIS CONSOLE IS THE ONLY ONE THAT CREATED A RUN- ON CONDITION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE END USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481095 ↗
• MalfunctionMay 16, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THERE ARE ISSUES WITH THE HANDPIECE STILL BEING ACTIVE WHEN THE CONSOLE IS ON SAFE MODE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338187 ↗
• MalfunctionAug 2, 2023Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE ACTIVATED THE HANDPIECE IN SAFE MODE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441790 ↗
• MalfunctionJul 24, 2023Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS TURNING A HANDPIECE ON WITHOUT ACTIVATION DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

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

  MAUDE report 17386075 ↗
• MalfunctionJun 15, 2023Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS WORKING AUTOMATICALLY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139973 ↗
• MalfunctionJun 2, 2023Break; Crack

  THE FRONT OF THE BOX CRACKED AND BROKE AWAY FROM THE MAIN PART OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049480 ↗
• MalfunctionApr 18, 2023Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS ACTIVATING DRILL WITHOUT A FOOT PEDAL DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765822 ↗
• MalfunctionJan 13, 2023Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS ACTIVATING ON ITS OWN DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161141 ↗
• MalfunctionDec 14, 2021Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE WAS OVERHEATING HANDPIECES DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003523 ↗
• MalfunctionJun 29, 2021Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE CAUSED OVERHEATING DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086204 ↗
• MalfunctionApr 1, 2021Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE AUTOMATICALLY SWITCHED TO REVERSE DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603664 ↗
• MalfunctionMay 18, 2020Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE IS CAUSING HANDPIECES TO ROTATE DURING ON ITS OWN DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

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

  MAUDE report 10065090 ↗
• MalfunctionJan 16, 2020Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE CAUSED UNINTENDED ACTIVATION DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9596027 ↗
• MalfunctionDec 12, 2019Unintended Power Up; Unintended Movement; Unintended Power Up; Unintended Movement

  THE USER FACILITY REPORTED THAT THE DEVICE WAS CHANGING SPEED ON ITS OWN DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 9460470 ↗
• MalfunctionJun 24, 2019Unintended Movement; Unintended Movement

  THE USER FACILITY REPORTED THAT THE DEVICE STARTED UNINTENTIONALLY RUNNING A HANDPIECE IN REVERSE TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8728981 ↗
• MalfunctionMay 31, 2019Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RAN UNINTENTIONALLY DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8658454 ↗
• MalfunctionMay 31, 2019Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RAN UNINTENTIONALLY DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8658217 ↗
• MalfunctionMay 31, 2019Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RAN UNINTENTIONALLY DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8658215 ↗
• MalfunctionMay 31, 2019Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RAN UNINTENTIONALLY DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8658166 ↗
• MalfunctionMay 31, 2019Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RAN UNINTENTIONALLY DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8658161 ↗
• MalfunctionApr 15, 2019Unintended Power Up; Unintended Movement; Unintended Power Up; Unintended Movement

  THE USER FACILITY REPORTED THAT THE DEVICE RAN OVER SPEED DURING A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8514929 ↗