NA gi4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00724995180256), received between Apr 21, 2022 and Aug 5, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 17, 2022Terminated

   Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

   Z-0241-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147366 ↗
• MalfunctionDec 23, 2025No Display/Image; No Display/Image

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR GI4000 ELECTROSURGICAL UNIT ARGON GAS CANISTER EMPTIES WITHIN MINUTES AND HAS A BLACK SCREEN RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT UNIT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879411 ↗
• MalfunctionNov 8, 2024Sparking; Sparking

  THE USER FACILITY REPORTED VIA MEDWATCH MW5162107 THAT WHEN THE ELECTROSURGICAL UNIT WAS ON THE ARGON PLASMA COAGULATION (APC) SETTING, A SPARK WAS OBSERVED FROM THE ARC SMART PROBE TIP WHEN THE APC WAS ENGAGED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644515 ↗
• MalfunctionApr 12, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, USER FACILITY PERSONNEL WERE UTILIZING THE ARGON PLASMA COAGULATION ON THE GI4000 ELECTRO SURGERY UNIT AND THE DISPLAY SCREEN THAT SHOWS THE ENDOSCOPE IMAGE "BLACKED OUT". THE PATIENT PROCEDURE WAS SUBSEQUENTLY CANCELLED. NO REPORT OF INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19097044 ↗
• MalfunctionJan 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THAT THE ARGON TO THEIR GI4000 ELECTROSURGICAL UNIT WAS NOT FIRING (DELIVERING ARGON) AS EXPECTED. THE USER FACILITY WAS NOT ABLE TO COMPLETE THE CASE WITH THE GI4000 ESU. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485378 ↗
• MalfunctionDec 15, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHILE USING A PULSE CUT ON THEIR GI4000 ESU, THE PATIENT EXPERIENCED A PERFORATION WHILE BEING TREATED FOR PANCREATITIS. THE PROCEDURE WAS NOT COMPLETED, AND A METAL STENT WAS PLACED TO HELP WITH THE PERFORATION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AS A PRECAUTION AND LATER THAT DAY IT WAS NOTED THAT THE PATIENT WAS BLEEDING. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT.

  Patient problems: Perforation

  MAUDE report 18335679 ↗
• MalfunctionJul 19, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE USING ARGON PLASMA COAGULATION (APC), THE PATIENT'S TISSUE APPEARED TO BE A DIFFERENT COLOR THAN EXPECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING CLIPS WHICH RESULTED IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 17350559 ↗
• MalfunctionApr 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THEIR GI4000 ELECTROSURGERY UNIT THE CAUTERIZATION WAS NOT WORKING AND THE SCREEN TO THE ESU WENT BLACK. A PROCEDURE DELAY OCCURRED AS USER FACILITY PERSONNEL HAD TO UTILIZE ANOTHER ELECTRO SURGERY UNIT. NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14172182 ↗