AUTOCON UH400URecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04048551378809), received between Nov 9, 2020 and Apr 3, 2026 — classified as 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THERE WAS A LOSS OF POWER DUE TO A LOOSE CONNECTION DURING PROCEDURE. THE BLACK POWER SOCKET IS LOOSE WHICH IS LEADING TO AN INTERMITTENT POWER LOSS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776326 ↗
• MalfunctionMar 18, 2026Sparking

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE IN A CADAVER LAB, WHILE USING THE ROBI BIPOLAR INSTRUMENTATION IN CONJUNCTION WITH THE AUTOCON 400 GENERATOR, WE OBSERVED SPARKING WHEN ATTEMPTING TO UTILIZE BOTH THE CUT AND COAGULATION FUNCTIONS. AS A RESULT, THREE ROBI INSTRUMENTS SUSTAINED DAMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634130 ↗
• MalfunctionFeb 9, 2026Overheating of Device

  IT WAS REPORTED THE DEVICE WAS OVERHEATING. NO PROCEDURE OR PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291842 ↗
• InjuryDec 3, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT "RESIDENT WAS SHOCKED USING BIPOLAR LOOP". CROSS REFERENCE MDRS: 9610617-2025-02200. 9610617-2025-02201. 9610617-2025-02202.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712381 ↗
• InjuryDec 3, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT "RESIDENT WAS SHOCKED USING BIPOLAR LOOP". CROSS REFERENCE MDRS: 9610617-2025-02200. 9610617-2025-02201. 9610617-2025-02202.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712380 ↗
• MalfunctionOct 20, 2025Electrical /Electronic Property Problem; Sparking; Electrical /Electronic Property Problem; Sparking

  ACCORDING TO THE INFORMATION RECEIVED, THE BOTTOM LEFT IS NOT RECOGNIZING COAGULATING AND DURING A PROCEDURE IT SPARKED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344045 ↗
• InjurySep 3, 2025Fire; Fire

  IT WAS REPORTED THAT THE BIPOLAR CORD CONNECTED TO THE HF GENERATOR SPARKED, PRODUCING FIRE AND SMOKE, AND APPEARING TO BE CHARRED. DURING THE PROCEDURE, THE PATIENT JERKED. HOWEVER, THE CUSTOMER IS UNSURE WHETHER THIS WAS DUE TO THEIR CURRENT PVCS AND ABNORMAL HEART RHYTHM OR TO THE OUTBREAK OF FIRE. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A BACK-UP CORD. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 22956625 ↗
• InjurySep 3, 2025Fire; Fire

  IT WAS REPORTED THAT THE BIPOLAR CORD CONNECTED TO THE HF GENERATOR SPARKED, PRODUCING FIRE AND SMOKE, AND APPEARING TO BE CHARRED. DURING THE PROCEDURE, THE PATIENT JERKED. HOWEVER, THE CUSTOMER IS UNSURE WHETHER THIS WAS DUE TO THEIR CURRENT PVCS AND ABNORMAL HEART RHYTHM OR TO THE OUTBREAK OF FIRE. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A BACK-UP CORD. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 22956624 ↗
• MalfunctionJul 2, 2025Break; Sparking; Break; Sparking

  IT WAS REPORTED DURING CYSTOSCOPY, BLUE LIGHT BLADDER TUMOR FULGARATION PROCEDURE, THE BIPOLAR CORD POPPED, SPARKED AND STOPPED WORKING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MEDWATCH 9610617-2025-01123.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387552 ↗
• InjuryApr 21, 2025Defective Component; Power Problem; Defective Component; Power Problem

  IT WAS REPORTED THAT INSUFFICIENT MONOPOLAR CAUTERY. PATIENT INVOLVED. PATIENT WAS INJURED, CUSTOMER HAD TO GET A BLOOD TRANSFUSION. PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH THE 5MM ROLLER-BALL MONOPOLAR ELECTRODE AND INSUFFICIENT CAUTERY CAUSED EXCESSIVE BLEEDING. COAGULATION WAS MAXED AT 120 WATTS. PATIENT HAD TO HAVE BLOOD TRANSFUSED. CROSS REFERENCE MFR REPORT # 1221826-2025-00639.

  Patient problems: Insufficient Information

  MAUDE report 21873751 ↗
• InjuryApr 21, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT INSUFFICIENT MONOPOLAR CAUTERY. PATIENT INVOLVED. PATIENT WAS INJURED, CUSTOMER HAD TO GET A BLOOD TRANSFUSION. PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH THE 5MM ROLLER-BALL MONOPOLAR ELECTRODE AND INSUFFICIENT CAUTERY CAUSED EXCESSIVE BLEEDING. COAGULATION WAS MAXED AT 120 WATTS. PATIENT HAD TO HAVE BLOOD TRANSFUSED. CROSS REFERENCE UF/IMPORTER REPORT # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21873744 ↗
• InjuryMar 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER USING AUTOCON, A BLOOD BLISTER-LIKE THING APPEARED AROUND WHERE THE [ERBE] ELECTRODE WAS ATTACHED. NO SYMPTOMS WHERE THE ELECTRODE CAME INTO DIRECT CONTACT WITH THE SKIN. THE PART NUMBER OF THE ELECTRODE IS BEING CONFIRMED. AUTOCON WAS PURCHASED AT THE OBSTETRICS AND GYNECOLOGY DEPARTMENT IN 2021 AND IS ALSO REGULARLY USED IN ORTHOPEDICS. ON THIS OCCASION, AUTOCON WAS USED FOR TOTAL JOINT REPLACEMENT SURGERY. THE CASE LASTED ABOUT 2 HOURS. THIS IS THE FIRST TIME THIS SYMPTOM HAS OCCURRED.

  Patient problems: Blister

  MAUDE report 21531719 ↗
• InjuryMar 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER USING AUTOCON, A BLOOD BLISTER-LIKE THING APPEARED AROUND WHERE THE [ERBE] ELECTRODE WAS ATTACHED. NO SYMPTOMS WHERE THE ELECTRODE CAME INTO DIRECT CONTACT WITH THE SKIN. THE PART NUMBER OF THE ELECTRODE IS BEING CONFIRMED. AUTOCON WAS PURCHASED AT THE OBSTETRICS AND GYNECOLOGY DEPARTMENT IN 2021 AND IS ALSO REGULARLY USED IN ORTHOPEDICS. ON THIS OCCASION, AUTOCON WAS USED FOR TOTAL JOINT REPLACEMENT SURGERY. THE CASE LASTED ABOUT 2 HOURS. THIS IS THE FIRST TIME THIS SYMPTOM HAS OCCURRED.

  Patient problems: Blister

  MAUDE report 21531716 ↗
• MalfunctionFeb 26, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE (CASE DATE/TYPE INFORMATION WAS NOT PROVIDED), THE DEVICE ENDED UP WITH WITH MULTIPLE BURNED CABLES AND LOOPS IN THE CASE. NO FURTHER INFORMATION WAS PROVIDED, OTHER THAN THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21474607 ↗
• InjuryJan 23, 2025Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED THAT THE CUTTING LOOP EXPLODED DURING A CASE. ACCORDING TO THE INFORMATION RECEIVED, THE CONSEQUENCE OF THE EXPLOSION IS THAT THE BLADDER WAS CHARRED. THE SURGEON WAS NOT CONCERNED ABOUT ANY LONG-TERM HARM TO THE PATIENT. CROSS REFERENCE MDR: 9610617-2025-00048, 9610617-2025-00049, 9610617-2025-00050, 9610617-2025-00051, 9610617-2025-00053, 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222500 ↗
• InjuryJan 23, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE CUTTING LOOP EXPLODED DURING A CASE. ACCORDING TO THE INFORMATION RECEIVED, THE CONSEQUENCE OF THE EXPLOSION IS THAT THE BLADDER WAS CHARRED. THE SURGEON WAS NOT CONCERNED ABOUT ANY LONG-TERM HARM TO THE PATIENT. CROSS REFERENCE MDR: 9610617-2025-00048, 9610617-2025-00049, 9610617-2025-00050, 9610617-2025-00051, 9610617-2025-00053, 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222326 ↗
• InjuryAug 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TURBT CASE ON (B)(6) 2024, THE DEVICE DID NOT WORK AND THE SURGEON COULD NOT CAUTERIZE THE TISSUE. THEY ALSO SMELL SMOKE OUT OF THE DEVICE, HOWEVER THERE THEY DID NOT SEE ANY SMOKE NOR THE DEVICE GOT HOT. THEY HAD TO BRING IN A BACK-UP TOWER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. HOWEVER, IT CAUSED A DELAY TO THE CASE OF ABOUT 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 19914286 ↗
• InjuryAug 5, 2024Blocked Connection; Insufficient Device Problem Information; Blocked Connection; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TURBT CASE ON JULY-02-2024, THE DEVICE DID NOT WORK AND THE SURGEON COULD NOT CAUTERIZE THE TISSUE. THEY ALSO SMELL SMOKE OUT OF THE DEVICE, HOWEVER THERE THEY DID NOT SEE ANY SMOKE NOR THE DEVICE GOT HOT. THEY HAD TO BRING IN A BACK-UP TOWER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. HOWEVER, IT CAUSED A DELAY TO THE CASE OF ABOUT 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 19914283 ↗
• MalfunctionDec 8, 2023Unintended Power Up; Adverse Event Without Identified Device or Use Problem; Unintended Power Up; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESECTOSCOPE MACHINE WAS SHOWING A FOOTSWITCH ERROR IN WHICH THE MACHINE WAS TURNED ON/OFF MULTIPLE TIMES. THE SURGEON THEN PROCEEDED TO USE THE MACHINE AND WHEN REMOVING THEIR FOOT FROM THE PEDAL THE MACHINE REMAINED ENGAGED. RESULTING IN A SMALL BURN ON THE UTERINE WALL OF A PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291401 ↗
• MalfunctionJun 8, 2023Sparking; Sparking

  IT WAS REPORTED THAT, DURING A TRANS URETHRAL RESECTION OF BLADDER TUMOR PROCEDURE ON (B)(6) 2023, THE WIRE SPARKED AND POPPED. NO PATIENT HARM WAS REPORTED. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE BY SWITCHING OUT THE BIPOLAR HIGH FREQUENCY CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087042 ↗
• MalfunctionDec 8, 2022Unexpected Shutdown; Unexpected Shutdown

  CUSTOMER REPORTED THAT THREE TIMES DURING ONE CASE AND TWO TIMES DURING ANOTHER THE GENERATOR JUST STOPPED WORKING. THE TOUCH SCREEN WAS FROZEN AND WAS NOT RESPONSIVE AND THE FOOT PEDAL DID NOT ACTIVATE THE GENERATOR. SYSTEM WAS SHUT DOWN AND RESTARTED; IT WORKED AND THEN FROZE AGAIN. THE PROCEDURE WAS COMPLETED USING A BACKUP GENERATOR. THERE WAS NO NEGATIVE PATIENT IMPACT. THIS REPORT REPRESENTS THE FIRST OF THE TWO CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947016 ↗
• MalfunctionDec 8, 2022Unexpected Shutdown; Unexpected Shutdown

  CUSTOMER REPORTED THAT THREE TIMES DURING ONE CASE AND TWO TIMES DURING ANOTHER THE GENERATOR JUST STOPPED WORKING. THE TOUCH SCREEN WAS FROZEN AND WAS NOT RESPONSIVE AND THE FOOT PEDAL DID NOT ACTIVATE THE GENERATOR. SYSTEM WAS SHUT DOWN AND RESTARTED; IT WORKED AND THEN FROZE AGAIN. THE PROCEDURES WERE COMPLETED USING A BACKUP GENERATOR. THERE WAS NO NEGATIVE PATIENT IMPACT. THIS REPORT REPRESENTS THE SECOND OF THE TWO CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946954 ↗
• InjuryDec 8, 2022Energy Spectrum Incorrect; Energy Spectrum Incorrect

  IT WAS REPORTED, THAT DURING TWO TURP CASES THE SURGEON WAS UNABLE TO STOP ARTERIAL BLEEDING, AND THE FULGURATION WAS EXTREMELY POOR. THE SURGERY TIME OF BOTH CASES WAS PROLONGED. THE PATIENT TREATED DURING THE FIRST CASE NEEDED TO BE REOPERATED, AS HE WAS STILL BLEEDING, AND NEEDED TO STAY IN THE HOSPITAL A FEW HOURS LONGER. BOTH PATIENTS WENT HOME THE SAME DAY. THIS REPORT REPRESENTS THE FIRST OF THE TWO CASES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15942356 ↗
• MalfunctionDec 8, 2022Energy Spectrum Incorrect; Energy Spectrum Incorrect

  IT WAS REPORTED, THAT DURING TWO TURP CASES THE SURGEON WAS UNABLE TO STOP ARTERIAL BLEEDING, AND THE FULGURATION WAS EXTREMELY POOR. THE SURGERY TIME OF BOTH CASES WAS PROLONGED. BOTH PATIENTS WENT HOME THE SAME DAY. THIS REPORT REPRESENTS THE SECOND OF THE TWO CASES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15941297 ↗
• MalfunctionSep 15, 2022Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT THE AUTOCON III UNIT STOPPED WORKING DURING A PROCEDURE AND THE CASE HAD TO BE CANCELED AS THEY DID NOT HAVE A BACKUP UNIT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427352 ↗