Coblation AC4045-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470003116), received between Feb 23, 2024 and Mar 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080282); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TOPAZ XL ELECTRODE WAS DETACHED. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942269 ↗
• MalfunctionFeb 23, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, THE TOPAZ WAND COULD NOT BE INSERTED TO THE BLACK SLOT. IT WAS NOT ABLE TO ABLATE NOR COAGULATE. BACK UP DEVICE WAS AVAILABLE. A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. AS PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION SHOWED THE ELECTRODE IS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080282. One submission often covers many models, so check the product and lot details in each record.

• Z-1321-2016 · Mar 3, 2016 · Terminated
  TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01