HET 180-1022Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521511132), received between Aug 13, 2018 and Apr 28, 2023 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Arcing” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROUTINE HEMORRHOIDECTOMY, THE PATIENT SUSTAINED A 1-2 MM 1ST DEGREE LINEAR SUPERFICIAL RECTAL BURN WITH NO TISSUE NECROSIS WHEN THE HET BIPOLAR FORCEPS "SPARKED" AND HAD ARCING WHEN NOT IN CONTACT WITH THE SELECTED TISSUE AREA. THE HET BIPOLAR FORCEPS WAS USED WITH ITS DESIGNATED COMPONENTS HET MONITOR AND FT10 GENERATOR. THE PATIENT WAS DISCHARGED HOME AFTER THE NORMAL POST PROCEDURE RECOVER PERIOD FOR HEMORRHOIDECTOMY WITH NO UNEXPECTED PAIN OR BLEEDING. PATIENT FOLLOW UP FOUND NO COMPLAINTS OR ANY SIDE EFFECTS. THERE WAS NO TREATMENT DONE TO THE PATIENT'S BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16829939 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT SUFFERED AN INTERNAL BURN.

  Patient problems: Burn(s)

  MAUDE report 16613530 ↗
• MalfunctionFeb 17, 2023Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE FAILED DURING THE PROCEDURE, WAS ABLE TO TREAT TWO AREAS AND BUT FAILED ON THE THIRD. THE DEVICE STOPPED WORKING AND THE PROVIDER WAS UNABLE TO COMPLETE HIS TREATMENT FOR HIS PATIENT. THEY ATTEMPTED TROUBLE SHOOTING IF A CONNECTION CAME LOOSE, BUT EVERYTHING WAS CONNECTED CORRECTLY, AS EXHIBITED BY THE INITIAL TREATMENTS THE PROVIDER WAS ABLE TO DO BEFORE THE MALFUNCTION. THAT WAS THEIR LAST DEVICE'S GUN, SO THE PROVIDER DID NOT GET TO COMPLETE HIS TREATMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16399577 ↗
• InjuryMay 19, 2022Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A HET (HEMORRHOID ENERGY THERAPY) CASE, THE DOCTOR TREATED THE PATIENT'S HEMORRHOIDS AT 3 O'CLOCK, 7 O'CLOCK, AND 11 O'CLOCK POSITIONS. DURING THE PROCEDURE THEY NOTICED THAT THE TEMPERATURE OF THE FORCEPS WAS DECREASING SLOWER THAN USUAL. THEY INSTRUCTED DR. (B)(6) TO TAKE THE FORCEPS OUT OF THE PATIENT AFTER EACH TREATMENT UNTIL THE FORCEPS WENT BACK TO ROOM TEMPERATURE. THE PATIENT DID NOT CALL WITH ANY POST PROCEDURE COMPLICATIONS. HOWEVER, APPROXIMATELY 10 DAYS POST PROCEDURE, THE DOCTOR CALLED TO INFORM THAT THE PATIENT WENT TO THE ER (EMERGENCY ROOM) DUE TO BLEEDING FROM THE RECTUM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14434834 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A LITERATURE, A PROSPECTIVE STUDY EVALUATED THE OUTCOMES OF PATIENTS WITH GRADE I OR II INTERNAL HEMORRHOIDS WHO UNDERWENT HEMORRHOID ENERGY TREATMENT FROM (B)(6) 2016 TO (B)(6) 2019. THE HET BIPOLAR SYSTEM WAS USED IN ALL PATIENTS. THERE WERE 73 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED PERSISTENT RECTAL BLEEDING. SIX PATIENTS REQUIRED A SECOND PROCEDURE DUE TO BLEEDING. THREE PATIENTS HAD PERSISTENT BLEEDING AFTER REPEAT PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12735899 ↗
• MalfunctionNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE POPPED AT 55. PATIENT HAD BURN DEEPER WITH LESS SURFACE AREA. ANOTHER DEVICE WAS USED.

  Patient problems: Burn(s)

  MAUDE report 9273740 ↗
• MalfunctionOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A SURGERY OF GRADE II HEMORRHOID TREATED WITH HET(HEMORRHOID ENERGY THERAPY), SMALL FISSURE WAS TREATED WITH TOPICAL CREAM AND WAS HEALED IN 2 WEEKS.

  Patient problems: No Code Available

  MAUDE report 9252203 ↗
• MalfunctionOct 25, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, AFTER A SURGERY OF INTERNAL HEMORRHOID WITH BLEEDING TREATED WITH (HEMORRHOID ENERGY THERAPY) HET, PATIENT HAD CLINICALLY SIGNIFICANT FISSURE. FISSURE WAS TREATED WITH TOPICAL CREAM AND RESOLVED IN 2 WEEKS. SURGEON SEEMED TO THINK THAT THE BULK OF THE INSTRUMENT AND THE NEED TO GET IT ABOVE THE DENTATE LINE WERE CONTRIBUTING FACTORS, ESPECIALLY IN PATIENTS WITH APPREHENSION WHO MIGHT HAD TIGHTER MUSCLE TONE IN THE AREA.

  Patient problems: No Code Available

  MAUDE report 9242160 ↗
• MalfunctionOct 25, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, AFTER A SURGERY OF GRADE III HEMORRHOID TREATED WITH (HEMORRHOID ENERGY THERAPY) HET, PATIENT HAD CLINICALLY SIGNIFICANT FISSURE AND BURNING SENSATION. SUSPECTED FISSURE WAS TREATED WITH TOPICAL CREAM AND RESOLVED IN 2 WEEKS. SURGEON SEEMED TO THINK THAT THE BULK OF THE INSTRUMENT AND THE NEED TO GET IT ABOVE THE DENTATE LINE WERE CONTRIBUTING FACTORS, ESPECIALLY IN PATIENTS WITH APPREHENSION WHO MIGHT HAD TIGHTER MUSCLE TONE IN THE AREA.

  Patient problems: No Code Available

  MAUDE report 9242143 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PROCEDURE WAS DONE ON (B)(6) 2018, AND THE PATIENT CAME TO THE EMERGENCY ROOM ON FRIDAY (B)(6) 2108, COMPLAINING OF SEVERAL RECTAL PAIN. UPON EXAMINATION, IT WAS DISCOVERED THAT THE BIPOLAR ENERGY WAS APPLIED BELOW THE DENTATE LINE AND CAUSED AN ULCER WHICH SCABBED OVER.

  Patient problems: No Code Available; Ulcer

  MAUDE report 8166793 ↗
• MalfunctionAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS POST HEMORRHOID ENERGY THERAPY, THE PATIENT DEVELOPED A RECTOCELE (POSTERIOR VAGINAL PROLAPSE) AND RECTAL PROLAPSE.

  Patient problems: Prolapse

  MAUDE report 7779107 ↗