SCOUT® 00884450433959Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450433959), received between Apr 16, 2024 and Apr 22, 2024 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024

  PLUGGED IT IN, PROCEEDED TO START USING IT, STARTED READING ERRONEOUS DEPTH TO OBJECT SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152402 ↗
• MalfunctionApr 16, 2024

  WE HAD AN ISSUE WHERE THE HANDPIECE WAS ACTING FUNNY AND WAS SAYING NO CONNECTION AND THEN IT WOULD BE READY THEN YOU WOULD HAVE TO PRESS THE START BUTTON MULTIPLE TIMES DURING THE PROCEDURE. WE COULD NOT DETERMINE AT THAT TIME IF IT WAS THE BASE OR THE HAND PIECE. ANOTHER HAND PIECE WAS OBTAINED THAT MATCHES THE SAME LOT # AND EXPIRATION DATE AND ITEM #. TURNED THE MACHINE OFF TO ALLOW IT TO REST, CAME BACK AND TURNED THE MACHINE BACK ON, PLUGGED THE NEW HAND PIECE IN THAT WE WERE PREPARED TO WASTE TO TEST IT WITH IT NEVER PRODUCED AN ISSUE. PLUGGED THE FIELDPIECE IN AGAIN AFTER A FEW MINUTES IT DID GIVE US WARNING. UNPLUGGED IT AND PLUGGED THE NEW HANDPIECE IN AGAIN JUST TO VERIFY, NO ISSUES UNPLUGGED IT ONE LAST TIME, AND WE STILL GOT AN ISSUE WITH A HANDPIECE THAT WAS IN THE FIELD. WE ARE SAYING AT THIS POINT, IT IS THE HANDPIECE, AND NOT THE CORD THAT'S ATTACHED THAT'S DISPOSABLE AND NOT THE MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114959 ↗