ENT MR8 1847DRLMTRRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000356958), received between Feb 28, 2023 and Jan 9, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Overheating of Device; Device Remains Activated; Difficult to Remove; Vibration

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, ALL THREE DRILLS WERE HEATING UP AT THE HAND PIECE AND ONE DRILL JUMPED FORWARD, CAUSING DAMAGE TO THE DURA. THE DRILL JUMPING FORWARD RESULTED IN A DURAL INJURY.

  Patient problems: Brain Injury; Dural Tear; Perforation

  MAUDE report 24017597 ↗
• MalfunctionNov 19, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT WHEN USING THE MOTOR WITH CUTTING BURR, THE PART HELD BY THE SURGEON BECAME SO HOT AND NO LONGER ABLE TO HOLD AND WHEN SURGEON PLACED IT ON THE SURGICAL FIELD, IT BURNED IT. THE MOTOR WAS CHANGED AND THE AFFECTED MOTOR WAS SENT FOR STERILIZATION AND REVISION. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596321 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PROCEDURE, DRILL OVERHEATED AND NEVER COOLDOWN. THIS ALMOST BURN THE HAND OF THE SURGEON. IT WAS ALSO REPORTED THAT THERE WAS A PROCEDURAL DELAY OF 10 MINUTES AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. ADDITIONAL DETAILS REGARDING PATIENT IMPACT IS BEING FOLLOWED UP FROM THE FACILITY.

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

  MAUDE report 23297321 ↗
• MalfunctionAug 20, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 22847917 ↗
• MalfunctionJul 17, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ENT MR8 WOULD START TO HEAT UP AFTER 30SEC TO 1 MINUTE OF USE AT 75000 RPM. HAND PIECE (DRILL) HEATS UP AND ATTACHMENTS WHEN USED ON THIS HAND PIECE. FAULTY ATTACHMENTS WOULD STILL HEAT UP WHEN USED WITH AN OTHER HAND PIECE (DRILL). FAULTY DRILL WOULD HEAT UP AND MAKE GOOD WORKING ATTACHMENTS HEAT UP ALSO. MULTIPLE TEST DONE WITH MULTIPLE ATTACHMENTS AND HAND PIECE (DRILL). THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528302 ↗
• MalfunctionApr 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE WITH THE REPORT OF OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884521 ↗
• MalfunctionApr 19, 2025Overheating of Device; Overheating of Device

  ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

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

  MAUDE report 21869997 ↗
• MalfunctionMar 12, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581046 ↗
• MalfunctionMar 12, 2025Difficult to Insert; Overheating of Device; Noise, Audible; Difficult to Insert; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT IT WAS DIFFICULT TO FIT THE ATTACHMENT TO THE MOTOR, DURING PROCEDURE THEY HEARD "STRANGE" NOISE COMING FROM THE MOTOR/ATTACHMENT AND THE ATTACHMENT STARTED TO BE HOTTER THAN USUAL. IT WAS REPORTED THAT THE DRILLING WAS STOPPED AND CUSTOMER SWITCHED TO BACKUP DEVICE TO COMPLETE THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580682 ↗
• MalfunctionFeb 3, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NO CODE AVAILABLE. NO PATIENT IMPACT REPORTED. THE REPAIR REQUEST WAS ESCALATED TO A PRODUCT EVENT DUE TO THE RETURN OF THE PART IN LESS THAN 90 DAYS FROM THE PURCHASE OR REPAIR. ON FOLLOW UP IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289934 ↗
• MalfunctionNov 22, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.  REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755355 ↗
• MalfunctionOct 14, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440511 ↗
• MalfunctionOct 1, 2024Overheating of Device; Loss of Power; Overheating of Device; Loss of Power

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO THE EVENT ESCALATED TO PRODUCT EVENT SINCE THE REPAIR AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20341515 ↗
• MalfunctionSep 30, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334845 ↗
• MalfunctionSep 27, 2024Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR AND BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20324935 ↗
• MalfunctionSep 24, 2024Misconnection; Overheating of Device; Physical Resistance/Sticking; Misconnection; Overheating of Device; Physical Resistance/Sticking

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF FAILURE TO COUPLE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292348 ↗
• MalfunctionSep 24, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292161 ↗
• MalfunctionMar 26, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977166 ↗
• MalfunctionSep 14, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT  BOTH MOTOR RUNS EXTREMELY WARM AND MOTOR HAS TOTALLY LOST BLUE SURFACE COLOR. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17742983 ↗
• MalfunctionJul 12, 2023Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303867 ↗
• MalfunctionJul 6, 2023Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17264976 ↗
• MalfunctionFeb 28, 2023Difficult to Insert; Overheating of Device; Difficult to Insert; Overheating of Device

  REPAIR REQUEST WAS INITIATED FOR THE DEVICE WITH THE REPORT OF THE BURS AND BLADES DOESN'T FIT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR AND ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16450874 ↗