PlasmaKinetic 786500Recalls & reported problems
Gyrus ACMI, LLC · PLASMAKINETIC SUPERPLUSE SYSTEM PK Button Front Loading Electrode · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925039520), received between Jul 26, 2022 and Feb 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THE ELECTROSURGICAL ELECTRODE HAD NO FUNCTION WHEN ACTIVATED. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TERP) PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24303484 ↗MalfunctionJul 26, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THE UNIT DID NOT WORK WHEN OPENED. NO ENERGY FLOWING THROUGH THE UNIT. ACCORDING TO THE REPORTER, THE USER RE-SEATED THE UNIT HOWEVER, THE UNIT DID NOT WORKED. USER TRIED ANOTHER UNIT AND IT WORKED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15108563 ↗
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- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.