Handpiece QS High Power For Harmony XL KJ count (100-120v)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17290110120525), received between Oct 27, 2017 and Feb 22, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S RIGHT LEG (ANKLE TO CALF) FOR TATTOO REMOVAL. THE FACILITY REPORTED SEVERE PAIN, BLISTERING AND SWELLING. AS PER THE FACILITY, THEY ADVISED THE PATIENT NOT TO PICK AT ANY SCABS OR BLISTERS, AND TO KEEP THE AREA CLEAN AND MOISTURIZED. LATER, THE PATIENT ADMITTED TO THE FACILITY THAT HE DRAINED HIS BLISTERS AND WEARS STEEL TOE BOOTS AT WORK. THE PATIENT WAS REQUESTED TO COME IN FOR EVALUATION BY THE FACILITY DOCTOR, HOWEVER, HE WENT TO THE ER. ACCORDING TO THE FACILITY, THE MEDICATION BEING USED IS IBUPROFEN. THE FACILITY STATED THEY FOLLOWED UP WITH THE PATIENT BUT HE HAS REFUSED TO COOPERATE AND DOES NOT FOLLOW INSTRUCTIONS.

  Patient problems: Burn(s)

  MAUDE report 8362654 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUSPECTED DEVICE (532 NM WAVELENGTH) WAS USED ON PATIENT'S ANKLE FOR TATTOO REMOVAL. THE FACILITY DIAGNOSED THE INJURY AS A BURN.

  Patient problems: Partial thickness (Second Degree) Burn; Skin Discoloration

  MAUDE report 7834462 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUSPECTED DEVICE WAS USED ON SKIN TYPE II PATIENT FOR RESURFACING PROCEDURE ON HER FOREHEAD. PATIENT HAS A HISTORY OF PERMANENT MAKEUP ON HER FOREHEAD. PERMANENT MAKEUP IS TAN IN COLOR TO COVER HYPOPIGMENTATION. ACCORDING TO THE FACILITY, FEW DAYS AFTER THE Q-SWITCH TREATMENT, PERMANENT MAKE UP TURNED BLUE. FACILITY NURSE DIAGNOSED THE CONDITION AS BLUE STREAKS ON PATIENT'S FOREHEAD.

  Patient problems: Skin Discoloration

  MAUDE report 7045880 ↗
• InjuryOct 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SUSPECTED DEVICE WAS USED ON SKIN TYPE III PATIENT FOR SKIN RESURFACING PROCEDURE ON FACE. THE PATIENT ALLEGED THAT HER SKIN WAS DENTED ON THE LEFT SIDE OF HER FACE(LOWER CHEEK AREA) AFTER THE LAST TREATMENT. BASED ON THE FACILITY NOTES THE PATIENT UNDERWENT 13 TREATMENTS WITH THIS SUSPECTED DEVICE.

  Patient problems: No Code Available

  MAUDE report 6983454 ↗