Harmonic Ace ACE14SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036000884), received between Jun 12, 2018 and Nov 16, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON FOUND THE TIP BROKEN AFTER USE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843072 ↗
• MalfunctionOct 4, 2018Device Displays Incorrect Message; Noise, Audible

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE SURGEON WORKED WITH ACE14S INSTRUMENT. AFTER THE SECOND ACTIVATION, DEVICE ERRORS OCCURRED AND DISPLAY SHOWED THE MESSAGE TO TIGHTEN ASSEMBLY. AFTER HE TIGHTENED THE INSTRUMENT, IT STARTED TO PRODUCE STRANGE SOUND, LIKE IT TOUCHED SOME METAL. HE WASN¿T ABLE TO FINISHED THE PROCEDURE WITH THE SAME SHEARS AND HE NEEDED TO CHANGE IT. PATIENT IS OK, AND THERE ARE NOT ANY COMPLICATIONS FOR HIM REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937107 ↗
• MalfunctionAug 8, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, WHEN THE DEVICE WAS ASSEMBLED, IT SHOWED ¿REPLACE INSTRUMENT¿ WHEN DEVICE WAS ACTIVATED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7765909 ↗
• MalfunctionJun 12, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN OPEN CABG, AN UNKNOWN ERROR OCCURRED DURING USE. THEN, THE DEVICE BECAME NOT TO FUNCTION. THE DEVICE WAS USED ON THE BLOOD VESSELS. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594181 ↗