Harmonic HARHPGRRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 20705036023422), received between Sep 5, 2023 and Sep 30, 2026 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (19 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947893 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE CAME APART. THE ISSUE WAS IDENTIFIED BEFORE USE, AND THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135824 ↗
• MalfunctionApr 30, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE GIVES A "CHANGE TOOL" ERROR AS IF A PROBE WERE ATTACHED, EVEN WHEN NO PROBE IS CONNECTED. THE HANDPIECE HAS A COUNTER. IT DOES NOT WORK WHEN DIFFERENT PROBES ARE TRIED. IT HAS BEEN TESTED WITH DIFFERENT GEN11 AND HARMONIC PROBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045866 ↗
• MalfunctionApr 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE HAS A BREAKDOWN. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033826 ↗
• MalfunctionApr 23, 2026Failure to Read Input Signal; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THIS DEVICE WAS FAULTY WITH NO INDICATION ON THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966397 ↗
• MalfunctionApr 8, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE DOES NOT WORK EVEN AFTER CHANGING ULTRACISION CLAMP "(41 USES) TEST X2".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816879 ↗
• MalfunctionMar 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE HAS RUST ON THEM. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598292 ↗
• MalfunctionMar 13, 2026Failure to Disconnect

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON HAS A HARHPGR THAT IS NOT CONNECTING PROPERLY TO THE HARMONIC DEVICES. NO PATIENT CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598068 ↗
• MalfunctionMar 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECES HAS RUST ON THEM. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591175 ↗
• MalfunctionMar 10, 2026Failure to Disconnect

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE HANDPIECE COULD NOT BE REMOVED FROM THE DEVICE. 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. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558848 ↗
• MalfunctionFeb 10, 2026Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304140 ↗
• MalfunctionJan 22, 2026Break; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCREW CONNECTION TO THE ENERGY DEVICES WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146766 ↗
• MalfunctionDec 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880470 ↗
• MalfunctionDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791637 ↗
• MalfunctionDec 12, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE NO LONGER CLIPS PROPERLY ONTO THE GENERATOR. NO PATIENT CONSEQUENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791568 ↗
• MalfunctionDec 12, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT, DURING AN UNKNOWN LAPAROSCOPIC SURGERY, THE HANDPIECE COULD NOT BE REMOVED AFTER THE OPERATION. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE BECAUSE THIS EVENT WAS FOUND AFTER USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789826 ↗
• InjurySep 15, 2025Failure to Read Input Signal; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Failure to Read Input Signal; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, AS SOON AS THE HANDPIECES WERE CONNECTED TO THE SCISSORS, AN ORANGE MESSAGE APPEARED SAYING "NO MORE USE LEFT." INSTEAD OF PROCEEDING, THEY CUT THE PATIENT COMPLETELY INSTEAD OF WORKING IN A CELIO. THEY USED THREE HANDPIECES TO COMPLETE THE OPERATION. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052346 ↗
• InjurySep 15, 2025Failure to Read Input Signal; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Failure to Read Input Signal; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, AS SOON AS THE HANDPIECES WERE CONNECTED TO THE SCISSORS, AN ORANGE MESSAGE APPEARED SAYING "NO MORE USE LEFT." INSTEAD OF PROCEEDING, THEY CUT THE PATIENT COMPLETELY INSTEAD OF WORKING IN A CELIO. THEY USED THREE HANDPIECES TO COMPLETE THE OPERATION. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052334 ↗
• InjurySep 15, 2025Failure to Read Input Signal; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Failure to Read Input Signal; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, AS SOON AS THE HANDPIECES WERE CONNECTED TO THE SCISSORS, AN ORANGE MESSAGE APPEARED SAYING "NO MORE USE LEFT." INSTEAD OF PROCEEDING, THEY CUT THE PATIENT COMPLETELY INSTEAD OF WORKING IN A CELIO. THEY USED THREE HANDPIECES TO COMPLETE THE OPERATION. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052296 ↗
• MalfunctionAug 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PAINT IS PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706215 ↗
• MalfunctionJul 23, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UROLOGICAL PROCEDURE THE HARHPGR HAS BEEN CONNECTED WITH GEN11 A MESSAGE APPEARED: "REPLACED HAND PIECE." 89 USAGES REMAIN IN THE HAND PIECE REPLACED THE HANDPIECE. THE PROCEDURE WAS DELAYED 10 MINUTES BUT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579848 ↗
• MalfunctionJun 12, 2025Failure to Read Input Signal; Protective Measures Problem; Failure to Read Input Signal; Protective Measures Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199983 ↗
• MalfunctionJun 12, 2025Failure to Read Input Signal; Insufficient Device Problem Information; Failure to Read Input Signal; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HAND PIECE HAS A CONNECTION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197737 ↗
• MalfunctionMay 21, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HAND PIECE DOESN'T WORK WHEN THEY CONNECT IT TO THE GENERATOR. THE GENERATOR GIVES A YELLOW SCREEN AND THE FOLLOWING MESSAGE "DEFECTIVE HAND PIECE, PLEASE REPLACE IT." NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063546 ↗
• MalfunctionMay 1, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE BLOCKAGE FROM THE FIRST ACTIVATION SAYING THAT THERE ARE NO MORE UNITS TO USE (ACCORDING TO THE WORDS OF THE NURSES). NO CONSEQUENCES FOR THE PATIENT BUT IT DELAYED THE INTERVENTION ALL THESE MANEUVERS WITH THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943745 ↗