Harmonic HP054Recalls & reported problems

Summary

The FDA's MAUDE database contains 793 adverse event reports that list this exact device (DI 20705036002144), received between Dec 4, 2017 and Sep 29, 2026 — classified as 7 injuries, 786 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (169 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 793 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936108 ↗
• MalfunctionMay 26, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING THE START UP OF THE UNKNOWN SURGERY, THE HARMONIC 700 AND HANDPIECE HP054 COULD NOT CONNECT TO THE GEN11 GENERATOR. A MESSAGE WAS DISPLAYED ON THE SCREEN: "REACTIVATE - TWO SWITCH ACTIVATIONS DETECTED. REACTIVATE INSTRUMENT TO CONTINUE." THE GENERATOR "FROZE" AND IT WAS NOT POSSIBLE TO PROCEED WITH ANY ACTION. AFTER A COUPLE OF TRIES, REDOING THE CONNECTION WITH THE HARMONIC 700, WE REPLACED THE HANDPIECE HP054 WITH ANOTHER HANDPIECE HARHPGR. IT THEN WORKED AS NORMAL. THE PROCEDURE WAS DELAYED 15 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279286 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN I CHECKED THE TEST WITH THE TEST CHIP, I WAS TOLD TO REPLACE IT, SO I WOULD LIKE TO CONFIRM THE CAUSE OF THE FAILURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863874 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING THE INSPECTION, WE FOUND A BREAK IN THE HAND SWITCH SIGNAL LINE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820934 ↗
• MalfunctionMar 13, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AN INSTRUMENT CONNECTION ERROR WAS DETECTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589945 ↗
• MalfunctionJan 14, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, AN ALERT SOUNDED BUT NO ERROR MESSAGE WAS DISPLAYED. 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 24067746 ↗
• MalfunctionDec 12, 2025Failure to Read Input Signal; Activation, Positioning or Separation Problem; No Apparent Adverse Event; Failure to Read Input Signal; Activation, Positioning or Separation Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN HARMONIC DEVICE WAS NOT WORKING PROPERLY. HARMONIC DEVICE WAS STRUGGLING TO GET THROUGH (SEAL & CUT) ANY SORT OF TISSUE ON ALL THREE SETTINGS OF THE INSTRUMENT (MIN, MAX, ADVANCE HAEMOSTASIS), WITH A COUPLE OF BLEEDS ALONG THE WAY WE WEREN'T ABLE TO CONTROL IN THE USUAL WAY. A COUPLE OF TIMES THE INSTRUMENT ALSO HAD 'RESET' MESSAGE ON GEN11 AND REQUIRED ACTIVATING NUMEROUS TIMES THROUGHOUT USE, WHEN USUALLY YOU ONLY NEED TO DO IT PRIOR TO USE. SCRUB NURSE WAS UNABLE TO CHECK THE LIVES ON THE LEAD AS SHE WAS SCRUBBED, NO WARNING PRIOR TO USE HAD BEEN GIVEN. THEY SWITCHED BOTH DEVICE AND HANDPIECE. PATIENT OUTCOME NOT EFFECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794296 ↗
• MalfunctionNov 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 23535700 ↗
• MalfunctionNov 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  GLOBAL BRAND PROTECTION LATAM TEAM HAS PERFORMED A TEST PURCHASE IN ECUADOR, IN ONE NON-AUTHORIZED AND SUSPICIOUS SELLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511111 ↗
• MalfunctionOct 27, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GREY HANDPIECE IS NOT SCREWING WITH THE PROBE. THE SHAFT IS ROTATING WITH THE SCREW FREELY, WHOLE ASSEMBLY OF HANDPIECE IS ROTATING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389556 ↗
• MalfunctionAug 18, 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 22833654 ↗
• MalfunctionJul 30, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS DAMAGE ON THE HANDLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665138 ↗
• MalfunctionJul 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING THE ASSEMBLY OF THE HARMONIC HANDPIECE-CLAMP SYSTEM, DIFFICULTIES WERE ENCOUNTERED BY THE BLOCK TEAM (SCREWING IN A VACUUM), WHICH LED TO THE CHANGE OF A HANDPIECE. SUBSEQUENTLY, FAILURE OF THE SYSTEM AND THEREFORE ATTEMPT TO RETIGHTEN AND RESET BUT IN VAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560074 ↗
• MalfunctionJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE IS NO LONGER FUNCTIONING; THERE ARE STILL 44 USES AVAILABLE ON THE HANDPIECE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559726 ↗
• MalfunctionJul 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS USE OF A NEW HANDPIECE, WHICH WAS DYSFUNCTIONAL, AND THEREFORE SWITCH TO A SINGLE-USE HARMONIC PLIERS WITH INTEGRATED HANDPIECE SO THAT THE BLOCK CAN CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559645 ↗
• MalfunctionJul 16, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A COLECTOMY THE HANDPIECE OF THE GEN11 GENERATOR, FROM THE BEGINNING DID NOT RECOGNIZE THE POWER CLAMP. IT IS NECESSARY TO CHANGE THE HANDPIECE FOR ANOTHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519194 ↗
• MalfunctionJul 15, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC REDO FUNDOPLICATION THE SCALPEL CORD NOT COORDINATING WITH MACHINE. WOULD SHOW YELLOW ERROR SCREEN WHEN TRYING TO FIRE IT DURING PROCEDURE. HAD TO OPEN A NEW CORD AND RECALIBRATE MACHINE WHICH THEREFORE DELAYED THE PROCEDURE AND INCREASED TIME PATIENT WAS UNDER ANESTHESIA. THE SURGERY WAS DELAYED 5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511777 ↗
• MalfunctionJul 9, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A ROUX-EN-Y THE HARMONIC 700 WAS CONNECTED TO THE HANDPIECE BUT THE GENERATOR CONTINUOUSLY SHOWED AN ERROR WHILE ACTIVATING. A NEW HARMONIC ACE+ WAS UNPACKED BECAUSE THEY DID NOT KNOW WHAT THE REASON WAS AND THOUGHT IT WAS THE HARMONIC DEVICE ITSELF. HOWEVER, AFTERWARDS WE TESTED THE HANDPIECE AND IT SHOWED IT WAS NOT FUNCTIONING (BUT STILL 3 USES LEFT OVER). THE PROCEDURE WAS DELAYED 5 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457923 ↗
• MalfunctionJun 13, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HAND PIECE IS NOT DETECTING THE SCISSORS. THE CUSTOMER HAS BEEN INFORMED THAT THE HAND PIECE IS OBSOLETE. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203310 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING THE LAPAROSCOPIC PROCEDURE, THE ROOT OF THE HANDPIECE WAS PEELED OFF, AND THE INTERNAL PART WAS VISIBLE. THE HANDPIECE COULD BE USED. 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 22176272 ↗
• MalfunctionMay 29, 2025Failure to Read Input Signal; Difficult or Delayed Activation; Failure to Read Input Signal; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS INTERMITTENT OPERATION OF THE INSTRUMENT, ACCOMPANIED BY ERROR MESSAGES WHICH LED TO A 15 MINUTE DELAY IN THE PROCEDURE. AFTER CHECKING, IT HAS 32 USES LEFT ON THE COUNTER. THEY DID CHANGE THE CABLE. NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106459 ↗
• MalfunctionMay 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A DEFECTIVE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106274 ↗
• MalfunctionMay 28, 2025Failure to Read Input Signal; Failure to Disconnect; Failure to Read Input Signal; Failure to Disconnect

  IT WAS REPORTED THAT AT THE BEGINNING OF THE BARIATRIC SURGERY, THE INSTRUMENT TECHNICIAN CORRECTLY ASSEMBLED THE HANDPIECE, AND THE GENERATOR SOON DISPLAYED A MESSAGE ASKING TO REPLACE THE INSTRUMENT. THE GENERATOR WAS CHANGED, AND WHEN ATTEMPTING TO REPLACE THE HANDPIECE, THE ONE THAT WAS CONNECTED BECAME STUCK IN THE HARMONIC. SEVERAL ATTEMPTS TO REMOVE IT WERE MADE BY THE INSTRUMENT TECHNICIAN AND THE PHYSICIAN, BUT THEY WERE UNSUCCESSFUL. THEREFORE, IT WAS NECESSARY TO MAKE A SUBSTITUTION SO THAT THE PROCEDURE COULD CONTINUE. A CLINICAL ENGINEERING STAFF MEMBER WAS CALLED, AND HE ALSO COULD NOT REMOVE THE HANDPIECE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100538 ↗
• MalfunctionMay 28, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE STOPPED WORKING. IT WAS TESTED ON OTHER GENERATORS AND SCISSORS BUT IT DID NOT WORK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100468 ↗
• MalfunctionMay 21, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE HAS 24 REMAINING INSERTS, CONTINUOUSLY DELIVERS ERROR MESSAGES. NO PATIENT OUTCOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062585 ↗