Gyrus ACMI 777000Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00821925009004), received between Dec 17, 2020 and Aug 11, 2026 — classified as 1 injury, 102 malfunctions.

The most frequently reported specific device problem is “Output Problem” (38 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211498 ↗
• MalfunctionJul 1, 2026Break

  THE CUSTOMER RETURNED THE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678140 ↗
• MalfunctionJun 6, 2026Circuit Failure

  THE ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF ASSET CHECK FAULTY. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE AUXILIARY CIRCUIT BOARD WAS FOUND TO HAVE LOW POWER OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418921 ↗
• MalfunctionApr 3, 2026Break; Degraded; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE G400 GENERATOR EXHIBITED A BROKEN TRANSISTOR 5 COMPONENT ON THE PEAK RADIO FREQUENCY BOARD, AND METAL CAUSED A SHORT CIRCUIT TO THE CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778633 ↗
• MalfunctionApr 2, 2026Degraded; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES PRODUCED OUTPUT OUTSIDE THE ACCEPTABLE RANGE, AND A FAULT WAS DETECTED ON THE AUXILIARY BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772582 ↗
• MalfunctionMar 31, 2026Circuit Failure

  IT WAS OBSERVED THAT THE POWER BOARD AND THE PLASMA BLEND DESATURATION ARE LOWER THAN THE LIMIT AND CAN'T BE ADJUSTED DUE TO FAULTY PLASMA BLEND BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749620 ↗
• MalfunctionMar 30, 2026Power Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR HAD NO OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728469 ↗
• MalfunctionNov 25, 2025Output Problem; Output Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES EXHIBITED A FAILURE IN PLASMA BLEND DESICCATION OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644503 ↗
• MalfunctionJul 29, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE GENERATOR EXPERIENCED A NO POWER OUTPUT PROBLEM DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650194 ↗
• MalfunctionApr 24, 2025Output below Specifications; Output below Specifications

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905100 ↗
• MalfunctionFeb 28, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE GENERATOR HAD BIPOLAR NOT ENGAGING/POWERING ON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21487597 ↗
• MalfunctionFeb 24, 2025Power Problem; Power Problem

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THAT THE GENERATOR HAD A FAULTY POWER SUPPLY UNIT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453955 ↗
• MalfunctionFeb 20, 2025Insufficient Heating; Insufficient Heating

  THE CUSTOMER REPORTED THAT AN OLYMPUS G400 GENERATOR WAS NOT PRODUCING ENOUGH HEAT IN THE MIDDLE OF A LAPAROSCOPIC HYSTERECTOMY. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS NOT GETTING HOT ENOUGH TO CAUTERIZING PROPERLY. REPORTEDLY, THE PROCEDURE WAS COMPLETED AFTER A 3-5 MINUTE DELAY BY USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421754 ↗
• MalfunctionNov 1, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE G400 GENERATOR EXHIBITED A FAILED OUTPUT DUE TO A FAULTY PLASMA BLEND BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587046 ↗
• MalfunctionSep 25, 2024Loss of Power; Loss of Power

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE G400 GENERATOR, GYRUS EXHIBITED A FAULTY POWER SUPPLY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301332 ↗
• MalfunctionSep 23, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED A FAULTY POWER SUPPLY UNIT (PSU) BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287875 ↗
• MalfunctionAug 14, 2024No Device Output; No Device Output

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GENERATOR HAD OUTPUT ISSUES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988115 ↗
• MalfunctionJul 12, 2024Output Problem; Output Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GENERATOR EXHIBITED OUTPUT ISSUES DUE TO A FAULTY PRINTED CIRCUIT BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731495 ↗
• MalfunctionJun 21, 2024Circuit Failure; Operating System Version or Upgrade Problem; Circuit Failure; Operating System Version or Upgrade Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED A FAULTY POWER SUPPLY UNIT (PSU), ISSUE WITH AN OLD VERSION PLASMA BLEND BOARD, AND FAULTY AUXILIARY (AUX) BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584225 ↗
• MalfunctionJun 10, 2024No Device Output; No Device Output

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GENERATOR EXHIBITED A FAULTY AUX BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504718 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GENERATOR EXHIBITED A FAULTY AUXILIARY BOARD FOUND WHEN THE NUMBER NINE SWITCH TEST FAILED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366423 ↗
• MalfunctionMay 21, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE G400 GENERATOR, GYRUS EXHIBITED ENERGY OUTPUT ISSUES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358089 ↗
• MalfunctionMay 16, 2024Break; Break

  IT WAS REPORTED THE ELECTROSURGICAL KNIFE INSULATION TIP DROPPED; INTO THE PATIENT¿S STOMACH AND WAS NOT RETRIEVED. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTRIC ESD. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336703 ↗
• MalfunctionMay 7, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE PROCEDURE WAS DELAYED BY TEN MINUTES TO ALLOW THE DEVICE TO BE SWITCHED. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259120 ↗
• MalfunctionMay 6, 2024Defective Component; Defective Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GENERATOR HAD A FAULTY AUXILIARY BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256463 ↗