Harmonic Ace ACE45ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705036000976), received between Jan 12, 2018 and Mar 21, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A REPLACE INSTRUMENT ERROR DURING THE CASE AFTER 3RD ACTIVATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840216 ↗
• MalfunctionAug 10, 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 Consequences Or Impact To Patient

  MAUDE report 10388343 ↗
• MalfunctionDec 4, 2019Device Fell

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WHITE TISSUE PAD HAD FALLEN OFF. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED OF. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414232 ↗
• MalfunctionOct 30, 2019Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 2 ACTUAL DEVICES FOR BLADE TIP BROKE OFF. THESE EVENTS OCCURRED DURING USE BY A HEALTHCARE PROFESSIONAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257460 ↗
• MalfunctionOct 3, 2019Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152870 ↗
• MalfunctionJul 19, 2019Break; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER OPENING THE STERILE PACKAGING, PLACING THE INSTRUMENT IN THE TROCAR, AND ITS FIRST ACTIVATION, THE PLASTIC COVER FELL OFF FROM THE JAW OF THE DEVICE. THE WHITE TISSUE PAD WAS COMPLETELY MISSING FROM THE CLAMP ARM OF THE DEVICE WHILE ITS FIRST ACTIVATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808084 ↗
• MalfunctionMar 21, 2019Break

  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 ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8442295 ↗
• MalfunctionJan 30, 2019Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A SOLID TONE WITH ERROR CODE 'TIGHTEN ASSEMBLY' WAS RECEIVED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290134 ↗
• MalfunctionJan 10, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADE TIP WAS BROKEN ABOUT 0.3 CM DURING THE PROCEDURE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE REPORTER CLAIMED THAT THE WHOLE SURGERY HAD BEEN PROLONGED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8238319 ↗
• MalfunctionDec 11, 2018Break

  IT WAS REPORTED THAT DURING AND UNKNOWN PROCEDURE, THE DOCTOR HELD THE MESENTERY, ACTIVATED THE PROBE, AND IMMEDIATELY IT BROKE. THIS PROBE WAS ONLY USED ON THIS CASE. THERE WAS NO ADVERSE EVENT FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153968 ↗
• MalfunctionDec 5, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A "TIGHTEN ASSEMBLY" ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135862 ↗
• MalfunctionSep 14, 2018Break

  IT WAS REPORTED THAT THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7878761 ↗
• MalfunctionSep 11, 2018Activation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE ACTIVATED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866804 ↗
• MalfunctionAug 21, 2018Break

  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 PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802004 ↗
• MalfunctionJul 31, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ERROR TONE WITH ERROR CODE 'RELAX PRESSURE ON BLADE' WAS RECEIVED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737423 ↗
• MalfunctionJun 29, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7653036 ↗
• MalfunctionJan 26, 2018Break

  IT WAS REPORTED THAT THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7222136 ↗
• MalfunctionJan 12, 2018Break

  IT WAS REPORTED THAT THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7188318 ↗