Coblation, TOPAZ Q6002-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470004373), received between May 30, 2022 and May 30, 2022 — classified as 2 injuries.

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.

• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "RADIOFREQUENCY COBLATION FOR CHRONIC FOOT AND ANKLE TENDINOSIS", 1 PATIENT HAD INCREASING PAIN AND DEFORMITY WITH INABILITY TO PERFORM SINGLE STRAIGHT LEG HEEL RAISING AFTER 6 MONTHS OF A RADIOFREQUENCY COBLATION PROCEDURE USING TOPAZ MICRODEBRIDER ICW WAND AND TOPAZ EPF MICRODEBRIDER ICW WAND. THE CONDITION WAS TREATED WITH A MEDIALIZING CALCANEAL OSTEOTOMY AND EVAN¿S LATERAL COLUMN LENGTHENING OSTEOTOMY PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 14541324 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "RADIOFREQUENCY COBLATION FOR CHRONIC FOOT AND ANKLE TENDINOSIS", 1 PATIENT DEVELOPED SUPERFICIAL WOUND DEHISCENCE AFTER A RADIOFREQUENCY COBLATION PROCEDURE USING TOPAZ MICRODEBRIDER ICW WAND AND TOPAZ EPF MICRODEBRIDER ICW WAND. IT IS UNKNOWN HOW THE CONDITION WAS TREATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 14541278 ↗

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