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Medline AC404501RHRecalls & reported problems

Medline Industries, Inc. · AC 4045-01 TOPAZ XL MICRODEBRIDER,W/INT · Class 2

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277383562), received between Feb 23, 2017 and Feb 23, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 Fragmentation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 23, 2017Material Fragmentation; Material Fragmentation

    WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ABLATION WAND DETACHED DURING USE. THE TIP WAS DETECTED VIA X-RAY AND WAS REMOVED AT THE TIME OF THE PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6354018 ↗

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Sources and updates

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