PlasmaBlade™ PS300-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169937949), received between May 31, 2023 and Sep 13, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Melted” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THAT THE REPLACE BLADE WAS NONSTERILE IN THE PACKAGE. THE DOCTOR CHANGED TO A NEW BADE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739120 ↗
• MalfunctionJul 14, 2023Melted; Melted

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT IN A CASE WHILE THEY WERE USING THE HANDPIECE DEVICE. IT HAD SEEMED THAT THE ADENOID TIP WAS MELTING DURING USE. THE SURGEON THEN STOPPED USING THE DEVICE AND PROCEEDED TO OPEN ANOTHER SET AS MAYBE THAT ONE WAS DEFECTIVE. THIS HAPPENED A TOTAL OF 4 TIMES AND THE SURGEON ABANDONED THE DEVICE. THERE WAS NO DELAY AND NO IMPACT TO PATIENT OUTCOME AND THE CASE PROCEEDED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329630 ↗
• MalfunctionJul 14, 2023Melted; Melted

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS DISCOVERED PRE-OPERATIVELY AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SCHEDULED AS A PEDIATRIC TONSILLECTOMY AND ADENOIDECTOMY AND THE STAFF NOTICED THE TONSIL TIPS WERE CLOGGED/CLOSED DIRECTLY OUT OF THE PACKAGING. A DIFFERENT HANDPIECE WAS USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329612 ↗
• MalfunctionMay 31, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE WIRE OF THE ADENOID TIP WAS BROKEN BEFORE UNPACKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032000 ↗