VISAO® 3334800 (UDI 00643169360938)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169360938), received between Mar 30, 2017 and Jun 3, 2025 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (55 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING THE OPERATION THE VISAO BALL TOOL WHIPS AND THE BALL TOOL DIDN¿T STAY IN THE AXIS OF ROTATION. THE CUSTOMER THINK THAT THE PROBLEM COME FROM EXTENDED BUR GUARD WITH IRRIGATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129679 ↗
• MalfunctionFeb 12, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, THE VISAO DRILL HAD BUR WOBBLING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362690 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, THE DEVICE HAD BUR WOBBLES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321446 ↗
• MalfunctionFeb 4, 2025Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION, THE BUR WOBBLES IN VISAO HANDPIECE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304643 ↗
• MalfunctionNov 11, 2024Leak/Splash; Overheating of Device; Leak/Splash; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE VISAO DRILL WAS HEATING UP WHEN USED AND OIL LEAKING OUT OF HANDPIECE. AS SOON AS HANDPIECE OVERHEATS, USER STOPPED USING IT IMMEDIATELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649544 ↗
• MalfunctionNov 8, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TESTING, THE LAB TECH STATED THAT THE NOSE BEARING BECAME HOT EXTREMELY FAST. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638134 ↗
• MalfunctionJul 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS OVERHEATING. OVERHEATING WAS NOTICED WITH IN ONE MINUTE OF USAGE. THE DEVICE WAS RUN AT THE SPEED OF 80000 RPM IN FORWARD MODE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PRE-TEMPERATURE TEST RESULT OF THE HANDPIECE FOR ONE MINUTE AT 80,000 RPMS, THE RESULT WAS 50.2 DEGREE CELSIUS(EXCEED 47.78DEGREE). THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834560 ↗
• MalfunctionJun 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, VISAO HANDPIECE WAS OVERHEATING WHEN RUNNING ABOUT 1 MINUTE. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545843 ↗
• MalfunctionJun 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP, THE VISAO DRILL WAS OVERHEATING AT ABOUT 1 MINUTE OF USAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545660 ↗
• MalfunctionMay 21, 2024Overheating of Device; Overheating of Device

  PRE-REPAIR TEMPERATURE TEST OF THE DEVICE PERFORMED FOR 1 MIN, FOUND THAT AT NOSE - 114.9F, MIDDLE - 115.9F AND REAR - 84.4F WHICH HAVE NOT EXCEEDED 118.4 F HENCE DOES NOT MEET THE REPORTING CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361530 ↗
• MalfunctionMar 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED DURING INTRA-OP THAT THE DEVICE HAD HOT BEARING AND NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966813 ↗
• MalfunctionJan 12, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING THE OPERATION, THE BUR WOBBLES. THE BEARING BEAD FELL OFF AND SHOOK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500750 ↗
• MalfunctionDec 4, 2023Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED, THE EVENT OCCURRED INTRA-OP AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253859 ↗
• MalfunctionAug 29, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SETUP, THE VISAO DRILL HAD NO POWER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643050 ↗
• MalfunctionAug 17, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE VISAO DRILL HANDPIECE OVERHEATING WAS NOTICED IN LESS THAN A MINUTE, WITH THE SPEED OF 8000RPM IN THE FORWARD MODE AND IRRIGATION WAS USED WITH 40CC/MIN. PROCEDURE WAS COMPLETED WITHOUT HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563538 ↗
• MalfunctionMar 10, 2023Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING PROCESS, VISAO DRILL WAS OVERHEATING AND JAMMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522957 ↗
• MalfunctionSep 29, 2022Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING SETUP HANDPIECE WAS OVERHEATING. NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505728 ↗
• MalfunctionSep 26, 2022Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING OPERATION HANDPIECE WAS OVERHEATING. NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT DEVICE WAS OVERHEATING IN LESS THAN ONE MINUTE, PROCEDURE WAS COMPLETED WITH SPARE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15489296 ↗
• MalfunctionAug 10, 2022Vibration; Vibration

  HEALTHCARE PROFESSIONAL REPORTED THAT THE DEVICE BUR WOBBLES DURING INTRA-OP. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED , VIBRATING DEVICE USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202350 ↗
• MalfunctionJul 18, 2022Overheating of Device; Overheating of Device

  HCP REPORTED THAT DURING OPERATION THE DEVICE OVERHEATS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041330 ↗
• MalfunctionApr 21, 2022Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT INTRA OP, THE DEVICE WAS JUMPING. THERE WAS NO PATIENT IMPACT. THERE WAS NO DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166960 ↗
• MalfunctionApr 19, 2022Overheating of Device; Overheating of Device

  THE DISTRIBUTOR REPORTED THAT WHEN THE DOCTOR INSTALLED THE HANDPIECE INTO THE IPC FOR TESTING DURING FES SURGERY, HE FOUND THE MOTOR OF THE HANDPIECE WOULD GET HOT AND THE BUR COULDN'T INSTALL INTO THE HANDPIECE. SO, THE DOCTOR DECIDED TO USE A BACKUP HANDPIECE TO COMPLETE THE SURGERY. NO INTERVENTION PERFORMED. THE SURGERY DELAYED FOR 10 MINUTES. NO PATIENT IMPACT. THE HEATING ISSUE OCCURRED LESS THAN A MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139763 ↗
• MalfunctionApr 2, 2022Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM HCP. IT WAS REPORTED THAT DIAGNOSTIC WAS REQUIRED. NO POWER. NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED, CARTRIDGE WAS OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13991999 ↗
• MalfunctionDec 6, 2021Vibration; Vibration

  IT WAS REPORTED THAT THE BUR WOBBLES IN THE DRILL DURING OPERATION. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, THE INFORMATION WAS UNKNOWN WHETHER THE DEVICE WAS USED ON PATIENT OR NOT. NO DELAY IN SURGERY, BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932948 ↗
• MalfunctionDec 2, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PREPARATION FOR USE/PRE-OP THE DRILL GETTING VERY HOT. THERE WAS NO PATIENT INVOLVED. NO PATIENT / USER COMPLICATIONS /HARMS AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915180 ↗