Harmonic ACE HAR23Recalls & reported problems

Summary

The FDA's MAUDE database contains 337 adverse event reports that list this exact device (DI 10705036014430), received between Dec 5, 2017 and May 11, 2026 — classified as 1 death, 1 injury, 335 malfunctions.

The most frequently reported specific device problem is “Material Separation” (60 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 337 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Activation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THEY OPENED NEW HAR23 PROBE FOR THE CASE. BUT MIN BUTTON IS NOT WORKING. MIN BUTTON SHOWING ERROR NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135626 ↗
• MalfunctionMay 4, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW DIDN'T CLOSE COMPLETELY. SO REPLACE THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071534 ↗
• MalfunctionApr 24, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, AN ERROR MESSAGE ¿REPLACE INSTRUMENT¿ WAS DISPLAYED. GEN11 WAS USED. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982342 ↗
• MalfunctionApr 22, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS BEING PLUGGED IN AND NO RESPONSE FROM THE DEVICE. NO SET-UP START AND TEST ACTIVATION WHEN PLUGGED IN. COMPLETELY DEAD. DEVICE WAS STERILE AND HAD TO OPEN ANOTHER ONE TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957999 ↗
• MalfunctionApr 7, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, THE PACKAGE WAS FOUND DAMAGED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802332 ↗
• MalfunctionMar 20, 2026Activation Problem

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE MIN BUTTON COULD NOT BE USED. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. THE NUMBER OF REMAINING USES OF HP054 WAS UNKNOWN. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE USING ONLY THE MAX BUTTON. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654308 ↗
• MalfunctionFeb 3, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GENERATOR RESTART AUTOMATICALLY. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246109 ↗
• MalfunctionJan 26, 2026Activation Problem

  IT WAS REPORTED THAT, DURING A COLECTOMY, THE MAX BUTTON COULD NOT BE USED. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177698 ↗
• MalfunctionJan 16, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT IN THE MIDDLE OF THE UNKNOWN SURGERY THE DEVICE STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095390 ↗
• MalfunctionDec 22, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THERE WERE SEVERAL INSTANCES WHERE THE OUTPUT LASTED FOR ABOUT 1 TO 2 SECONDS IMMEDIATELY AFTER THE DEVICE WAS STOPPED TO USE AND THE JAWS WERE OPENED. THE JAWS WERE OPENED SECURELY AND THE DEVICE WAS USED WITH CAUTION TO AVOID BURNS. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. THE NUMBER OF REMAINING USES OF HARHPGR WAS UNKNOWN. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864287 ↗
• MalfunctionDec 4, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY THE SCISSORS DO NOT TURN OFF AFTER PRESSING THE BUTTON; THEY CONTINUE TO RUN. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720280 ↗
• MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN RESPIRATORY SURGERY, THE TISSUE PAD WAS CAME OFF. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687331 ↗
• MalfunctionOct 22, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCISSORS FROM THIS BATCH REMAINED PERMANENTLY ACTIVATED AFTER A SHORT PERIOD OF TIME. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359010 ↗
• MalfunctionOct 22, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCISSORS FROM THIS BATCH REMAINED PERMANENTLY ACTIVATED AFTER A SHORT PERIOD OF TIME. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358982 ↗
• MalfunctionOct 10, 2025Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING OPEN CORPECTOMY, THE ERROR DID NOT OCCUR IN SE, BUT THE BLADE BROKE. THE PIECES WERE ALREADY COLLECTED. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265458 ↗
• MalfunctionSep 19, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096469 ↗
• MalfunctionAug 11, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776941 ↗
• MalfunctionAug 8, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749743 ↗
• MalfunctionAug 8, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749590 ↗
• MalfunctionAug 8, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749469 ↗
• MalfunctionJul 30, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE "NO INSTRUMENT USES REMAINING" SCREEN WAS DISPLAYED BY THE GENERATOR. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664436 ↗
• MalfunctionJul 10, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472144 ↗
• MalfunctionJul 10, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470959 ↗
• MalfunctionJul 10, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470691 ↗
• MalfunctionJul 10, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE THE SCALPEL PASSED FIRST PRE-RUN TEST. AFTER WORKING SEVERAL MINUTES, THE SCALPEL WAS REQUIRED TO PRE-RUN BY THE SYSTEM AGAIN. THE SCALPEL COULD NOT WORK UNINTERRUPTED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470475 ↗