Elite+ 100-7018-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841494100063), received between Nov 29, 2018 and Jun 9, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (8 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 16, 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.

• MalfunctionJun 9, 2026Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT AN ELITE+ CABLE WAS SPARKING AND PRODUCING POPPING SOUNDS WHILE FIRING LASER ON ITS OWN DURING TREATMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25450491 ↗
• MalfunctionMay 11, 2026Unexpected/Unintended Radiation Output

  SITE REPORTED ELITE+ WAS FIRING LASER ON ITS OWN WITHOUT A FOOT PEDAL CONNECTED PRIOR TO STARTING TREATMENT. NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141965 ↗
• MalfunctionJan 12, 2026Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE ELITE+ WILL NOT STOP FIRING LASER PULSE AND UNIT KEEPS SAYING TO RELEASE SWITCH. SITE RELAYED THAT THIS HAS HAPPENED TWICE AND THEY HAD TO TURN OFF THE DEVICE TO STOP THE FIRING. OPERATOR ALSO MENTIONED THAT THE LCD DISPLAY WAS SHOT BY ACCIDENT DUE TO FIRING NONSTOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038415 ↗
• MalfunctionAug 20, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  SITE REPORTED ELITE+ WAS PRODUCING MORE ENERGY THAN EXPECTED. ON AUG 13, 2025 SITE RELAYED TO CYNOSURE CLINICAL THAT WHEN THEY WENT TO CHECK THE HANDPIECE, THE HANDPIECE WAS POINTED AT THE GROUND AND IT FIRED FROM THE BACK OF THE HANDPIECE WHERE WIRE WAS BROKEN. ALTHOUGH OPERATOR'S GLOVE WAS BURNED, OPERATOR DID NOT EXPERIENCE AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853156 ↗
• MalfunctionAug 13, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  SITE REPORTED THAT THE ELITE+ WAS NOT WORKING SO PROVIDER SWITCHED OUT THE FIBER FROM THE 20MM HANDPIECE. AFTER SWITCHING THE FIBER, PROVIDER HEARD A POP AND ENERGY WAS SHOT TOWARDS HER.

  Patient problems: Burn(s)

  MAUDE report 22794757 ↗
• InjuryMay 1, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  ON 24 APR 2024, CONTRACT MANUFACTURER COGMEDIX REPORTED TO CYNOSURE AN ACCIDENTAL RADIATION OCCURRENCE (ARO), WHICH OCCURRED DURING THE MANUFACTURING ASSEMBLY PROCESS OF ELITE+ SN (B)(6) ON 16 FEB 2023. DURING THE ASSEMBLY PROCESS, THE YAG ROD WAS INSTALLED BACKWARDS AND CAUSED THE LASER TO FIRE BACKWARDS UNEXPECTEDLY. NO INJURIES WERE REPORTED. PER THE PROCEDURE, A PROTECTIVE SHIELD IS TO BE USED DURING THE ASSEMBLY PROCESS AND IT WAS NOT BEING USED AT THE TIME OF THE REPORTED INCIDENT. COGMEDIX HAS INITIATED CORRECTIVE ACTION CA-100634 TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226121 ↗
• MalfunctionMar 15, 2024Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED THAT THE ELITE+ MISFIRED DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918275 ↗
• MalfunctionJan 8, 2021Radiation Underexposure; Radiation Underexposure

  IT WAS REPORTED THAT THE HANDPIECE WAS RECALIBRATING CONTINUOUSLY, AND UPON INSPECTION DEVICE WAS FOUND TO BE OUT OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140049 ↗
• InjuryDec 26, 2019Use of Device Problem; Use of Device Problem

  PATIENT REQUIRED MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9521572 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8894596 ↗
• MalfunctionApr 30, 2019Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  THE DEVICE'S HANDPIECE CONTINUED TO DISCHARGE ENERGY AFTER RELEASING THE TRIGGER BUTTON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564971 ↗
• MalfunctionNov 29, 2018Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  THE DEVICE'S HANDPIECE CONTINUED TO DISCHARGE ENERGY AFTER RELEASING THE TRIGGER BUTTON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117728 ↗