n.a. 27040EBRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04048551075623), received between Dec 18, 2018 and May 8, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Sparking

  THE EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT DURING THE PROSTATE RESECTION SURGERY. THE DOCTOR REPORTED THAT THERE WAS A SPARK COMING FROM THE HANDPIECE, BIPOLAR WORKING ELEMENT. THE HANDPIECE WAS REPLACED IMMEDIATELY, AND THE SURGEON CONTINUED THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-1060.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129403 ↗
• MalfunctionFeb 6, 2026Smoking

  IT WAS REPORTED THAT "AFTER ACTIVATING THE HF ENERGY, SMOKE DEVELOPED AT THE CONNECTION BETWEEN THE 27040EB AND THE HF CABLE.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283327 ↗
• MalfunctionJan 26, 2026Smoking

  IT WAS REPORTED THAT BIPOLAR CORD STARED SMOKING AT WORKING ELEMENT CONNECTION SITE. IT WAS CONFIRMED THAT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH A NEW WORKING ELEMENT AND CORD, WITH A 10 MINUTE DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179809 ↗
• InjuryDec 3, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT "RESIDENT WAS SHOCKED USING BIPOLAR LOOP". CROSS REFERENCE MDRS: 9610617-2025-02199. 9610617-2025-02201. 9610617-2025-02202.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712383 ↗
• InjuryDec 3, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT "RESIDENT WAS SHOCKED USING BIPOLAR LOOP". CROSS REFERENCE MDRS: 9610617-2025-02199. 9610617-2025-02201. 9610617-2025-02202.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712382 ↗
• 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, 9610617-2025-00052, 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222445 ↗
• InjuryJan 23, 2025Loss of or Failure to Bond; Excessive Heating; Loss of or Failure to Bond; 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:9610617-2025-00048,9610617-2025-00049,9610617-2025-00050,9610617-2025-00051,9610617-2025-00052,9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222413 ↗
• InjurySep 11, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE INSTRUMENT DOES NOT WORK CORRECTLY, IT DOES NOT CUT, THE WORKING ELEMENT HEATS UP, THE HANDLES OF CONSUMABLES ARE DAMAGED, IT HAS ALREADY CAUSED HARM TO A PATIENT. ADVERSE CONSEQUENCES FOR THE PATIENT: URETHRAL INJURY, DIAGNOSIS FROM CYSTOSCOPY, URETHRAL INJURY WITH TEARING AND BLEEDING. THE PATIENT IS OUT OF THE HOSPITAL AND IS UNDER OBSERVATION. THE PATIENT WAS GIVEN AN APPOINTMENT IN A MONTH TO PERFORM A CYSTOSCOPY AND CHECK THE PATIENT'S PROGRESS. CROSS REFERENCE IS COVERED UNDER MEDWATCH: 9610617-2024-00310.

  Patient problems: Insufficient Information

  MAUDE report 20192257 ↗
• InjurySep 11, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE INSTRUMENT DOES NOT WORK CORRECTLY, IT DOES NOT CUT, THE WORKING ELEMENT HEATS UP, THE HANDLES OF CONSUMABLES ARE DAMAGED, ADVERSE CONSEQUENCES USER: THE DOCTOR SUFFERED A BURN FROM THE WORKING ELEMENT. CURRENTLY THE DOCTOR NO LONGER HAS ANY INJURIES AND IS DOING. IT HAS ALREADY CAUSED HARM TO A PATIENT HARM TO PATIENT IS COVERED UNDER MEDWATCH 9610617-2024-00309.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20192223 ↗
• InjurySep 11, 2024Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  IT WAS REPORTED THAT THE INSTRUMENT DOES NOT WORK CORRECTLY, IT DOES NOT CUT, THE WORKING ELEMENT HEATS UP, THE HANDLES OF CONSUMABLES ARE DAMAGED, ADVERSE CONSEQUENCES USER: THE DOCTOR SUFFERED A BURN FROM THE WORKING ELEMENT. CURRENTLY THE DOCTOR NO LONGER HAS ANY INJURIES AND IS DOING. IT HAS ALREADY CAUSED HARM TO A PATIENT HARM TO PATIENT IS COVERED UNDER MEDWATCH 9610617-2024-00309.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20191999 ↗
• InjurySep 11, 2024Temperature Problem; Activation Failure; Temperature Problem; Activation Failure

  IT WAS REPORTED THAT THE INSTRUMENT DOES NOT WORK CORRECTLY, IT DOES NOT CUT, THE WORKING ELEMENT HEATS UP, THE HANDLES OF CONSUMABLES ARE DAMAGED, IT HAS ALREADY CAUSED HARM TO A PATIENT. ADVERSE CONSEQUENCES FOR THE PATIENT: URETHRAL INJURY, DIAGNOSIS FROM CYSTOSCOPY, URETHRAL INJURY WITH TEARING AND BLEEDING. THE PATIENT IS OUT OF THE HOSPITAL AND IS UNDER OBSERVATION. THE PATIENT WAS GIVEN AN APPOINTMENT IN A MONTH TO PERFORM A CYSTOSCOPY AND CHECK THE PATIENT'S PROGRESS. CROSS REFERENCE IS COVERED UNDER MEDWATCH: 9610617-2024-00310.

  Patient problems: Insufficient Information

  MAUDE report 20191880 ↗
• MalfunctionSep 26, 2019Electrical Overstress; Electrical Overstress

  ALLEGEDLY PER THE CUSTOMER, DURING A TURBT THE DOCTOR WAS ATTEMPTING TO "CUT" INTERMITTINGLY AND THE TISSUE COAGULATED AND FUSED THE URETERAL ORIFICE. A URETAL STENT WAS PLACED IN THE ORIFICE AND THE PROCEDURE WAS COMPLETED. POST OPERATIVELY THE PATIENT IS DOING FINE PER NURSE.

  Patient problems: Burn(s)

  MAUDE report 9122747 ↗
• MalfunctionSep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, DURING A BLADDER RESECTION TO CAUTERIZE A BLEEDING URETHRA, AN ERUPTION OCCURRED INSIDE THE PATIENT'S BLADDER WHICH CAUSED A PERFORATION OF THE BLADDER.

  Patient problems: Internal Organ Perforation

  MAUDE report 8972198 ↗
• MalfunctionMar 29, 2019Mechanical Problem; Mechanical Problem

  ALLEGEDLY, DURING A TRANS-URETHRAL RESECTION OF THE PROSTATE, FORTY MINUTES INTO THE OF SURGERY, THE PATIENT'S OBTURATOR NERVE WAS STIMULATED DURING THE PROSTATE RESECTION; AS A RESULT, THE PROSTATE CAPSULE WAS PERFORATED AND THERE WAS BLEEDING. THE SURGEON FELT HEAT AT THE HANDLE AND COULD SEE SMOKE, THEREFORE, HE STOPPED THE SURGERY. HE CHANGED INSTRUMENTS FOR A MONOPOLAR RESECTOSCOPE TO CONTROL THE BLEEDING. THE PATIENT WAS HOSPITALIZED OVERNIGHT. THE PATIENT WILL NEED A SECOND SURGERY TO COMPLETE THE RESECTION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8464984 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  WE WERE SERVED WITH A LEGAL DOCUMENT, RESPONDENTS IN DISCOVERY, FOR A LAWSUIT AGAINST TWO FACILITIES. THE COMPLAINT INDICATED THE PATIENT UNDERWENT A CYSTOSCOPY WITH URETHRAL DILATION, TRANSURETHRAL RESECTION/ABLATION OF PROSTATE WITH "BUTTON TYPE BIPOLAR PROSTATE RESECTOR" AND ALLEGEDLY SUFFERED THERMAL INJURY TO HIS BLADDER AND URETHRA.

  Patient problems: Burn, Thermal

  MAUDE report 8177027 ↗