MaXcess 3200220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517183378), received between Aug 16, 2016 and Oct 4, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 4, 2023Smoking; Smoking

  THE SURGEON WAS USING AN ANGLED LIGHT GUIDE WITH A RETRACTOR. THE LIGHT WAS PLUGGED IN TO AN INTEGRA LIGHT SOURCE WITH NO ADAPTER AND THE INTENSITY WAS SET TO 100% WITH PATIENT ON THE TABLE. AFTER ABOUT A MINUTE OF BEING TURNED ON THERE WAS A BURNING SMELL. I NOTICED SMOKE COMING OUT OF THE LIGHT BOX. I TURNED IT OFF AT THE WALL AND REMOVED THE LIGHT SOURCE. THE SMOKE TRIGGERED THE SMOKE ALARM IN THE THEATRE REQUIRING EMERGENCY TEAM RESPONSE AND THERE WILL BE AN INVESTIGATION BY THE FIRE WARDEN AT THE HOSPITAL. THE HOSPITAL HAVE RETAINED THE LIGHT SOURCE FOR INVESTIGATIVE PURPOSES. THERE WAS NO HARM TO THE PATIENT BUT SHORT DELAY THE SURGERY WAS COMPLETED WITHOUT THE LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873265 ↗
• InjuryAug 16, 2016Overheating of Device; Overheating of Device

  ON (B)(6) 2016 A FEMALE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. UPON COMPLETION OF THE FIXATION, THE RETRACTOR WAS REMOVED AND IT WAS NOTED THAT THE PATIENT HAD INCURRED A FULL-THICKNESS BURN ON THE LOWER BACK BENEATH THE RETRACTOR.

  Patient problems: Burn(s)

  MAUDE report 5880561 ↗