Pro PLP2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854061289), received between Jan 31, 2023 and Jan 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Self-Activation or Keying

  MID OPERATION THE CAUTERY BEGAN TO MALFUNCTION. THE CAUTERY BEING USED WAS A PLUME PEN CAUTERY (CAUTERY WITH SMOKE EVACUATOR). THE SMOKE EVACUATOR MACHINE AND CAUTERY MACHINE WERE SIMULTANEOUSLY RUNNING ON THEIR OWN WITHOUT ANYONE PRESSING THE BUTTON CAUSING A BURN TO THE PATIENT'S RIGHT SHOULDER. WHEN ISSUE WAS RECOGNIZED, TEAM STOPPED USING CAUTERY MACHINE AND SWITCHED TO A DIFFERENT CAUTERY MACHINE. ISSUE CONTINUED WITH NEW MACHINE, SO THE PLUME PEN CAUTERY WAS COMPLETELY UNPLUGGED AND REPLACED WITH NORMAL CAUTERY PEN (ONE PROVIDED IN THE ORTHO BASIC PACK). AFTER REPLACING PLUME PEN CAUTERY NO OTHER ISSUES WERE NOTED. SURGEON WAS PRESENT FOR EVENT. ORTHO MANAGER WAS NOTIFIED. 2 CAUTERY MACHINES AND SMOKE EVACUATOR MACHINE WERE REMOVED FROM THE OR FOLLOWING THE PROCEDURE AND REPLACED WITH NEW CAUTERY MACHINE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16271310 ↗