Plasmablade® PS300-002Recalls & reported problems
Medtronic, Inc. · PLASMABLADE PS300-002 TNA TIP RD MPSS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169628434), received between Sep 6, 2017 and Sep 19, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break1
- Energy Output Problem1
- Melted1
- Peeled/Delaminated1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2023Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A TONSILLECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17774782 ↗MalfunctionAug 26, 2021Peeled/Delaminated; Peeled/Delaminated
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT THE TIP WITH HIGHLY INSULATED ELECTRODE PART WAS PEELED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12371088 ↗MalfunctionMay 2, 2019Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE USED IN AN EAR NOSE AND THROAT PROCEDURE. IT WAS REPORTED THE ADENOID WIRE WAS BROKEN. IT WAS NOTED THE DEVICE WOULD BE RETURNED. IT WAS NOTED THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS LISTED AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. IT WAS NOTED THE PATIENT'S DEMOGRAPHIC INFORMATION WOULD NOT BE MADE AVAILABLE DUE TO LEGAL/CONFIDENTIAL REASONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573499 ↗MalfunctionSep 6, 2017Melted; Melted
DURING AN ENT CASE, THE PLASMABLADE DEVICE TIP MELTED. THERE WAS NO INJURY OR HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6844560 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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