Harmonic HARHPBLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705036023446), received between Aug 21, 2024 and Feb 25, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 25, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HAND PIECE BLUE HAS ERODED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443500 ↗
• MalfunctionNov 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE EXECUTION OF THE OPERATIVE PROCEDURE IN THE PAROTID REGION AND NECK AREA; WHILE PREPARING THE INSTRUMENTS AND CONNECTING THE HARMONIC FOCUS SCISSORS, A SEPARATION WAS OBSERVED BETWEEN THE UPPER METAL PART AND THE REST OF THE METAL SEGMENT TO WHICH THE SILICONE CABLE IS ATTACHED. THE INCIDENT OCCURRED AT THE BEGINNING OF THE SURGICAL PROCEDURE, DURING THE VERIFICATION OF THE FUNCTIONALITY OF THE DEVICE AND INSTRUMENTS. NO CONSEQUENCES WERE RECORDED FOR THE PATIENT, MEDICAL STAFF, OR THE ENVIRONMENT. THE SURGICAL PROCEDURE WAS CONTINUED WITHOUT ADDITIONAL COMPLICATIONS. ACCORDING TO THE HOSPITAL STAFF, THERE WAS NO MECHANICAL MANIPULATION IN TERMS OF UNPROFESSIONAL HANDLING, NOR WAS THERE ANY FALL OF THE INSTRUMENT. THE INSTRUMENT WAS USED IN ACCORDANCE WITH STANDARD PROCEDURES. AFTER EACH USE, THE INSTRUMENTS ARE: MECHANICALLY WIPED WITH A DAMP CLOTH, DISINFECTED, STORED IN A DESIGNATED BOX, STERILIZED IN A UV STERILIZER BEFORE THE START OF THE NEXT SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610070 ↗
• MalfunctionAug 25, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE THEY HAVE CHECKED ALL THE CONNECTIONS WITH THE SAME RESULTS = THE CONNECTION WITH THE GENERATOR IS ON AND OFF. WHEN THEY THEN SWITCHED TO THE OTHER HANDPIECE THERE HAVE BEEN NO PROBLEMS. BUT WITH THIS CABLE, IT LOOSES CONTACT WITH THE GENERATOR. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884319 ↗
• MalfunctionAug 21, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE HANDPIECE FAILED SHORTLY AFTER START OF THE THYROID PROCEDURE. THE HANDPIECE STILL HAS 53 INSERTS. THEY TRIED IT TWICE, TOOK EVERYTHING APART, SHUT DOWN GEN AND TESTED AGAIN. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018991 ↗