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ViSAO® 31181098ERecalls & reported problems

Medtronic Xomed, Inc. · BUR 31181098E VISAO 1MM 98 L 20DG DIAMD · Class 1

All models of ViSAO (16)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074322216), received between Jan 13, 2017 and Mar 3, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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

Device problems

  • Material Fragmentation4
  • Break2

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Device Embedded In Tissue or Plaque1
  • No Consequences Or Impact To Patient1
  • Oversedation1
  • Radiation Exposure, Unintended1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 3, 2020Break; Material Fragmentation; Break; Material Fragmentation

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT BACK IN (B)(6) 2019 THEY HAD A PRODUCT FAILURE WHEN THE TIP OF A BUR CURVED FINE DIAMOND BUR BROKE OFF INTRA-OPERATIVELY. THIS RESULTED IN THE PATIENT NEEDING AN ON TABLE X-RAY AND EXTENDED TIME UNDER ANESTHETIC. THE BUR TIP WAS FOUND AND THE OPERATION WAS COMPLETED.

    Patient problems: Oversedation; Radiation Exposure, Unintended

    MAUDE report 9780472 ↗
  • MalfunctionApr 5, 2018Break; Break

    THE CUSTOMER REPORTED THAT THE TIP OF THE VISAO CURVED BUR BROKE OFF. THERE WAS NO REPORTED INJURY AND NO ADDITIONAL INFORMATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7398918 ↗
  • MalfunctionApr 4, 2018Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED THAT THE TIP OF THE VISAO CURVED BUR BROKE OFF. THERE WAS NO REPORTED INJURY; NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7396296 ↗
  • InjuryApr 4, 2018Material Fragmentation; Material Fragmentation

    DURING A BILATERAL COCHLEAR PROCEDURE, THE VISAO CURVED BUR TIP BROKE OFF INSIDE OF A PATIENT AND MIGRATED INTO THE PATIENT VESTIBULE. AS A RESULT, THE SURGEON ATTEMPTED TO "DRILL OUT" [ENLARGE] THE AREA IDENTIFIED BY IMAGING TO RETRIEVE THE FRAGMENT. REPORTS INDICATE THAT THE PATIENT LEFT THE OR WITH THE "RETAINED ITEM."

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7396144 ↗
  • MalfunctionJan 13, 2017Material Fragmentation; Material Fragmentation

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SURGERY WAS COMPLETED WITH ANOTHER VISAO BUR (PRODUCT # 31181098E).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6251273 ↗

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Sources and updates

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