PicoSure 100-7012-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841494100001), received between Mar 21, 2018 and Sep 10, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (5 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  SITE REPORTED PICOSURE LASER FIRING WITHOUT OPERATOR STEPPING ON THE FOOTSWITCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015574 ↗
• MalfunctionAug 29, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  SITE REPORTED SHOT OF LASER GOING OFF WITHOUT OPERATOR STEPPING ON THE FOOTSWITCH WHILE USING PICOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922518 ↗
• MalfunctionAug 7, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE PICOSURE DEVICE WAS FIRING CONTINUOUSLY WITHOUT OPERATOR TOUCHING THE FOOT PEDAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929028 ↗
• InjuryJun 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION ON THE LEG 4 DAYS POST TREATMENT USING PICOSURE. IT IS LIKELY THAT PATIENT DID NOT FOLLOW POST TREATMENT INSTRUCTIONS.

  Patient problems: Skin Infection

  MAUDE report 19627282 ↗
• InjuryJul 25, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN AND HYPERPIGMENTATION ON THE LEG FOLLOWING A TREATMENT USING PICOSURE.

  Patient problems: Burn(s); Scar Tissue; Skin Discoloration

  MAUDE report 15099152 ↗
• MalfunctionNov 12, 2021Radiation Underexposure; Radiation Underexposure

  IT WAS REPORTED THAT A SECOND PATIENT EXPERIENCED BLISTERS FOLLOWING A PIGMENTATION TREATMENT USING PICOSURE. FIRST PATIENT WAS REPORTED IN MDR# 1222993-2021-00043.

  Patient problems: Blister

  MAUDE report 12805627 ↗
• MalfunctionNov 12, 2021Radiation Underexposure; Radiation Underexposure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLISTERS FOLLOWING A PIGMENTATION TREATMENT USING PICOSURE.

  Patient problems: Blister

  MAUDE report 12805357 ↗
• MalfunctionMar 27, 2020Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  THE CUSTOMER REPORTED THAT THE PICOSURE HANDPIECE HAD CONTINUED TO DELIVER AN UNINTENDED DISCHARGE OF LASER ENERGY AFTER THE TRIGGER BUTTON WAS RELEASED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889673 ↗
• MalfunctionJul 26, 2019Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  THE DEVICE'S HANDPIECE DISCHARGED UNINTENDED ENERGY DURING START UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830875 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A KELOID SCAR ON THE ARM FOLLOWING A TATTOO REMOVAL LASER PROCEDURE.

  Patient problems: Scarring

  MAUDE report 8153391 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ALLEGED HYPERTROPHIC SCARRING FOLLOWING A TATTOO REMOVAL LASER PROCEDURE.

  Patient problems: Scarring

  MAUDE report 8072048 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED SIGNIFICANT ERYTHEMA AND HISTAMINE RESPONSE FOLLOWING A LASER PROCEDURE ON HANDS/CHEST/FACE AREA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7357326 ↗