Visao™ 3334800TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885074107349), received between Feb 27, 2017 and Jan 25, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED INTRA INTRA-OP THE VISAO DRILL HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579423 ↗
• MalfunctionJun 5, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE VISAO DRILL HANDPIECE DEVELOPED HEAT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058951 ↗
• MalfunctionDec 7, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE IS WOBBLING DURING USE. ON FOLLOW-UP, IT WAS MENTIONED THAT THE DEVICE WAS VIBRATING WHILE USING ON THE PATIENT, DURING A TYMPANOPLASTY PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AND NO BACKUP DEVICE WAS USED. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12951497 ↗
• MalfunctionAug 5, 2021Degraded; Overheating of Device; Noise, Audible; Degraded; Overheating of Device; Noise, Audible

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE OVERHEATED DURING USE. ON FOLLOW UP, IT WAS REPORTED THAT IT TOOK OVER ONE MINUTE BEFORE OVERHEATING OCCURRED. A BACK UP DEVICE WAS USED TO FINISH THE PROCEDURE WITH NO DELAY. IT WAS ALSO REPORTED THAT THERE IS NO IMPACT ON NEITHER THE PATIENT NOR THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281926 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Overheating of Device; Fluid/Blood Leak; Overheating of Device

  A HEALTH CARE PROVIDER REPORTED THAT THE HANDPIECE WAS OVERHEATING AND THE OIL WAS LEAKING DURING TYMPANOPLASTY. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11983035 ↗
• MalfunctionJun 1, 2020Vibration; Connection Problem; Vibration; Connection Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BUR CANNOT BE INSERTED AND THAT THE BUR SHAKES WHEN ROTATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106909 ↗
• MalfunctionDec 21, 2018Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE HANDPIECE OVERHEATED AFTER STARTING TO WORK. THERE WAS NO IMPACT SUCH AS BURN INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191787 ↗
• MalfunctionApr 27, 2018Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468626 ↗
• MalfunctionJan 5, 2018Overheating of Device; Overheating of Device

  THE PHYSICIAN REPORTED THAT DURING A TYMPANOPLASTY, "WHEN THE FOOT SWITCH WAS STEPPED ON, THE DRILL ABNORMALLY OSCILLATED. THE HIGH-SPEED DRILL DID NOT OVERHEAT BUT HEATED [GOT WARM]. THE DRILL WAS NOT TOO HOT TO BE HELD BY HAND." THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167413 ↗
• MalfunctionNov 2, 2017Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THE DEVICE OVERHEATED AFTER A FEW MINUTES OF USE DURING A TYMPANOPLASTY. THE PRODUCT ANALYSIS CONFIRMS THE REPORTED EVENT OF OVERHEATING. THERE WAS NO DELAY TO THE PROCEDURE AND NO INJURIES REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997676 ↗
• MalfunctionJun 2, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608320 ↗
• MalfunctionFeb 27, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TYMPANOPLASTY SURGERY THE HANDPIECE OVERHEATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6360930 ↗