Gyrus ACMI 744000Recalls & reported problems
Gyrus ACMI, LLC · PLASMAKINETIC SUPERPULSE Generator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Gyrus ACMI PlasmaKinetic SuperPulse generator is an electrosurgical generator used for cutting and coagulation. The 237 reports mostly describe the generator giving weak or no energy output and circuit board problems, many found during device evaluation, with several noting no patient was involved. The reports include 2 injuries and no deaths. No recalls name this device, and reports fell to 16 in the last 12 months from 34 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 237
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 00821925009271), received between Apr 27, 2020 and Aug 25, 2026 — classified as 2 injuries, 235 malfunctions.
The most frequently reported specific device problem is “Output Problem” (81 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.
Reports received per month
Most reported problems
Device problems
- Output Problem81
- Electrical /Electronic Property Problem40
- No Device Output25
- Energy Output Problem21
- Break13
- Communication or Transmission Problem13
- Output below Specifications12
- Circuit Failure8
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- No Consequences Or Impact To Patient8
- No Patient Involvement7
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435011 ↗MalfunctionMay 23, 2026Communication or Transmission Problem
IT WAS REPORTED THE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES EXHIBITED ERROR MESSAGE: CHECK IRRIGANT, ELECTRODE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264757 ↗MalfunctionMay 22, 2026Corroded; Degraded; Melted; Intermittent Loss of Power; Incomplete or Inadequate Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR HAD CORROSION INSIDE THE ELECTRODE MOUNT, BURNT MARKS ON PRINTED CIRCUIT BOARD AND INTERMITTENT POWER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256376 ↗MalfunctionMay 10, 2026Circuit Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR HAD FAULTY PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133292 ↗MalfunctionApr 28, 2026Intermittent Loss of Power
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR EXHIBITED A FAULTY SPRF BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25021911 ↗MalfunctionApr 13, 2026Communication or Transmission Problem; Material Deformation; Material Integrity Problem
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GENERATOR HAD A DAMAGED SUPPORT BRACKET AND DISPLAYED ERROR CODE 200. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857559 ↗MalfunctionApr 10, 2026Electrical /Electronic Property Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL CUTTING, COAGULATION, AND ACCESSORY COMPONENTS EXPERIENCED ERROR 200 (REFERENCE 92). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839948 ↗MalfunctionApr 6, 2026Energy Output Problem; Failure to Calibrate
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR EXPERIENCED FAILURES ON THE PLASMA KINETIC RADIO FREQUENCY (PKRF) BOARD AND THE SOCKET SELECT BOARD (SPRF CONNECTOR). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796281 ↗MalfunctionApr 1, 2026Electrical /Electronic Property Problem; Failure to Recalibrate
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GENERATOR HAD A BOARD THAT FAILED CALIBRATION AND A FAULTY IDENTIFICATION BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757084 ↗MalfunctionMar 31, 2026Break
IT WAS OBSERVED DURING THE DEVICE EVALUATION THE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES CORE OF PLASMA KINETIC RADIO FREQUENCY BOARD WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747334 ↗MalfunctionMar 20, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES HAD ERROR CODE 426. THE ISSUE OCCURRED DURING SEDATION WHILE THE DEVICE WAS OUTSIDE THE PATIENT FOR A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653541 ↗MalfunctionMar 9, 2026Activation, Positioning or Separation Problem; Output Problem
IT WAS REPORTED THAT THE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES HAD INTERMITTENTLY WORKED. THE ISSUE WAS FOUND DURING UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545295 ↗MalfunctionFeb 19, 2026Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389381 ↗MalfunctionFeb 9, 2026Unexpected Shutdown
IT WAS REPORTED THE GENERATOR HAD ENERGY LOSS DURING CUTTING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291501 ↗MalfunctionDec 30, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923805 ↗MalfunctionNov 14, 2025Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555821 ↗MalfunctionSep 10, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022535 ↗MalfunctionSep 8, 2025Output Problem; Output Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD LOW OUTPUT WHILE TESTING THE DESSICATE. THE ISSUE OCCURRED DURING SERVICE/MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991866 ↗MalfunctionSep 3, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO OUTPUT. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956852 ↗MalfunctionAug 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A FAULTY CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906493 ↗MalfunctionAug 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD FAILED THE BURN-IN ON THE SUPERPULSE (SP) SIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787602 ↗MalfunctionAug 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FAULTY ID (CONTROL) BOARD AND UNIT FAILED THE ID TUNING TEST AS TUNING WAS FROZEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743396 ↗MalfunctionAug 6, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22724069 ↗MalfunctionJul 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A DAMAGED TR5 OF PKRF BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22652311 ↗MalfunctionJul 29, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BROKEN SPRF BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646454 ↗
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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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