Harmonic Ace ACE36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 860 adverse event reports that list this exact device (DI 10705036000938), received between Aug 23, 2017 and Jul 22, 2022 — classified as 4 injuries, 856 malfunctions.

The most frequently reported specific device problem is “Break” (575 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 860 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED ANOTHER DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088642 ↗
• MalfunctionJul 22, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED ANOTHER DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088572 ↗
• MalfunctionJul 22, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED ANOTHER DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088214 ↗
• MalfunctionJul 13, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009565 ↗
• MalfunctionApr 19, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A THYROIDECTOMY THE ACE36E WAS NOT WORKING. THE PROCEDURE WAS DELAYED 10 MINUTES. IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142919 ↗
• MalfunctionJan 13, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿TIGHTEN ASSEMBLY ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254373 ↗
• MalfunctionDec 22, 2021Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A LUNG RESECTION THE ¿TIGHTEN ASSEMBLY¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. THEN TITANIUM TIP WAS BROKEN DURING PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060850 ↗
• MalfunctionDec 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACOSCOPIC MEDIASTINAL LYMPH NODE DISSECTION. THE TITANIUM TIP OF ULTRASOUND SCALPEL SUDDENLY BROKE DURING THE SURGERY, LEADING TO INTRAOPERATIVE SEARCH FOR THE BROKEN END AND RESIDUE, RESULTING IN INCREASED SURGICAL RISK. AFTER DOZENS OF MINUTES OF SEARCH, THE BROKEN END AND RESIDUE WERE ALL REMOVED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057640 ↗
• MalfunctionDec 17, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026356 ↗
• MalfunctionOct 1, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565407 ↗
• MalfunctionAug 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACOSCOPIC MEDIASTINAL MASS EXCISION UNDER GENERAL ANESTHESIA, AND THE ULTRASONIC SCALPEL WAS CHECKED INTACT AND COMPLETE BEFORE THE START OF THE SURGERY. THE TEST OF CONNECTING THE ULTRASONIC SCALPEL GENERATOR WAS NORMAL. THE TITANIUM TIP WAS BROKEN BEFORE PREPARING TO ENTER THE THORACIC CAVITY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319053 ↗
• MalfunctionMay 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE ABOUT 1 HOUR INTO BEING USED. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866558 ↗
• MalfunctionMay 14, 2021Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT DURING A ABDOMINOPERINEAL RESECTION THE JAW WAS NOT WORKING. IT WAS STUCK UP IN THE HP054. THE SURGERY WAS DELAYED ABOUT 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826562 ↗
• MalfunctionMar 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACTIVE BLADE BROKE. THE SURGERY WAS DELAYED 5 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585650 ↗
• MalfunctionMar 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY THE ACTIVE BLADE BROKE. THE PROCEDURE WAS DELAYED 15 MINUTES BUT IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570131 ↗
• MalfunctionMar 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLADE BROKE DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456696 ↗
• MalfunctionMar 1, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392154 ↗
• MalfunctionFeb 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE TITANIUM TIP WAS BROKEN DURING A PROCEDURE OF LAPAROSCOPIC STAGING OF ENDOMETRIAL CARCINOMA. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11280588 ↗
• MalfunctionJan 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL COULD NOT PASS THE PRE-RUN TEST. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216610 ↗
• MalfunctionJan 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148183 ↗
• MalfunctionDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKEN. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021727 ↗
• MalfunctionDec 8, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿TIGHTEN ASSEMBLY¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968222 ↗
• MalfunctionDec 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HYSTERECTOMY THE HARMONIC BLADE BROKE DURING SURGERY. THE BROKEN PIECE WAS REMOVED. CHANGED TO A NEW PROBE AND RESTARTED THE SURGERY. THE SURGERY WAS DELAYED 20 MINUTES BUT IT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944319 ↗
• MalfunctionNov 25, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10900236 ↗
• MalfunctionNov 25, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACTIVE BLADE WAS BROKEN DURING ACTIVATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10900116 ↗