Coblation, TOPAZ Q6000-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00817470004380), received between May 25, 2022 and May 30, 2022 — classified as 8 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 8 most recent of 8 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 A COMPARISON OF RADIOFREQUENCY-BASED MICROANATOMY AND ARTHROSCOPIC RELEASE OF THE EXTENSOR CARPI RADIALIS BREVIS TENDON IN RECALCITRANT LATERAL EPICONDYLITIS: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY, 1 PATIENT HAD A PERSISTENT SWELLING AND PAIN DUE TO HEMATOMA DERIVED AT THE FIRST POSTOPERATIVE WEEK AFTER A RF BASED MICROANATOMY PROCEDURE USING A TOPAZ MICRO DEBRIDER COBLATION WAND. DESPITE 3 ASPIRATIONS AND 2 CORTICOSTEROID INJECTIONS, THE PATIENT UNDERWENT REVISION DUE TO RECURRENT SWELLING AT THE SURGICAL SITE AT 5 MONTHS AFTER THE PRIMARY OPERATION. IN THE OPERATION FIELD, THE RETRACTED ECRB WAS DEBRIDED AND THEN REATTACHED TO THE LATERAL EPICONDYLE WITH DECORTICATION USING 1 SUTURE ANCHOR. SWELLING WAS NOT OBSERVED AND PAIN WAS RELIEVED AFTER REVISION OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14541418 ↗
• 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 "MEDIUM-TERM RESULTS AFTER TREATMENT OF RECALCITRANT LATERAL EPICONDYLITIS", AFTER A MICROTENOTOMY PROCEDURE WHERE A TOPAZ MICRODEBRIDER WAND WAS USED, 1 PATIENT UNDERWENT REOPERATION WITH AN OPEN RELEASE DUE TO AN UNSPECIFIED REASON. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14541374 ↗
• 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 "EFFECTIVENESS OF BIPOLAR RADIOFREQUENCY IN THE OPERATIVE TREATMENT OF LATERAL EPICONDYLITIS", AFTER A MICRODEBRIDEMENT PROCEDURE WHERE A TOPAZ MICRODEBRIDER WAND WAS USED, 6 PATIENTS HAD A PERSISTENT PAIN REQUIRING REOPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 14541358 ↗
• 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 14541340 ↗
• 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 "FASCIAL INCISION AND ADHESIOLYSIS COMBINED WITH RADIOFREQUENCY MICROTENOTOMY IN TREATMENT OF CHRONIC MIDPORTION ACHILLES TENDINOPATHY", 1 PATIENT HAD A DEEP VENOUS THROMBOSIS AFTER A FASCIAL INCISION AND ADHESIOLYSIS COMBINED WITH RADIOFREQUENCY MICROTENOTOMY PROCEDURE USING A TOPAZ MICRODEBRIDER ICW WAND. THE EVENT WAS TREATED WITH ANTICOAGULANTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14541316 ↗
• 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 14541289 ↗
• 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 "FASCIAL INCISION AND ADHESIOLYSIS COMBINED WITH RADIOFREQUENCY MICROTENOTOMY IN TREATMENT OF CHRONIC MIDPORTION ACHILLES TENDINOPATHY", 1 PATIENT HAD A POST OPERATIVE SUPERFICIAL WOUND INFECTION AFTER A FASCIAL INCISION AND ADHESIOLYSIS COMBINED WITH RADIOFREQUENCY MICROTENOTOMY PROCEDURE USING A TOPAZ MICRODEBRIDER ICW WAND. THE EVENT WAS TREATED WITH ORAL ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14541257 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "MEDIUM-TERM RESULTS AFTER TREATMENT OF RECALCITRANT LATERAL EPICONDYLITIS", DURING A MICROANATOMY PROCEDURE WHERE A TOPAZ MICRODEBRIDER WAND WAS USED, 2 PATIENTS REQUIRED ADDITIONAL SEDATION DUE TO AN UNSPECIFIED REASON. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14500917 ↗

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