N/A (REF HARH45)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327346244), received between Aug 9, 2017 and Jan 9, 2026 — classified as 1 death, 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (6 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Fracture; Use of Device Problem

  IT WAS REPORTED THAT THE HARH45 DEVICE FAILED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS JUST TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019700 ↗
• MalfunctionNov 26, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem

  IT WAS REPORTED "THE TIP OF THE HARMONIC SHEARS BROKE OFF INSIDE THE PATIENT DURING THE LAPAROSCOPIC PROCEDURE. THE HARMONIC WAS REMOVED AND THE TIP THAT BROKE OFF INSIDE THE PATIENT WAS RETRIEVED BY THE SURGEON." ALL PIECES WERE REPORTED TO HAVE BEEN RETRIEVED BY THE SURGEON. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS REPORTED; HOWEVER, THE COMPLAINANT IS NOT AWARE OF THE DURATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660126 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HARMONIC SCALPEL STOPPED WORKING IN THE MIDDLE OF CASE. GENERATOR AND HANDPIECE BEING TESTED AS WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE COMPLAINANT IS NOT AWARE OF THE DURATION OF THE EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561954 ↗
• MalfunctionJul 16, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT HARMONIC SCALPEL INSTRUMENT MADE A NOISE AND CONSEQUENTIALLY BROKE INSIDE OF PATIENT. THE BROKEN PIECE WAS RETRIEVED AND REMOVED FROM PATIENT, ALONG WITH THE INSTRUMENT. THERE WAS NO PATIENT INJURY AND THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19756849 ↗
• MalfunctionJan 31, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE HARH45 FAILED AND THERE WAS NO POWER. THE DEVICE WOULDN¿T CONNECT TO THE UNIT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 2-3 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273396 ↗
• MalfunctionMay 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE HARMONIC ACE 7 STOPPED WITHIN A COUPLE OF MINUTES OF USE DURING THE PROCEDURE. UPON INSPECTION, THE TIPS WERE MELTED AND PULLING APART. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523512 ↗
• MalfunctionApr 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE HARH45 HARMONIC SHEARS DEVICE WOULD NOT WORK AFTER 2 COAGULATIONS, AND A PLASTIC PIECE POPPED OFF. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14246543 ↗
• MalfunctionApr 26, 2022Melted

  HARMONIC ACE 7 STOPPED WITHIN A COUPLE MINUTES OF USE DURING THE PROCEDURE. UPON INSPECTION, THE TIPS WERE MELTED AND PULLING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206146 ↗
• MalfunctionFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED, "THE HARMONIC TIP BROKE OFF IN THE CAVITY FOLLOWING ACTIVATION/USE." THE TIP WAS REMOVED THROUGH THE SAME INCISION, AND AN X-RAY WAS NOT REQUIRED TO LOCATE THE PIECE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME WAS 10-15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563102 ↗
• MalfunctionJul 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE BLADE OF THE DEVICE BROKE IN THE PATIENT. THE DETACHED PIECE WAS FOUND AND REMOVED WITHOUT AN X-RAY OR A LARGER INCISION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250318 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TEFLON PAD BURNED THROUGH AND THE DEVICE WAS REPLACED. THE CUSTOMER CONFIRMED THAT NO PIECES OF THE DEVICE FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773403 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TEFLON PAD BURNED THROUGH AND THE DEVICE WAS REPLACED. THE CUSTOMER CONFIRMED THAT NO PIECES OF THE DEVICE FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773390 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TEFLON PAD BURNED THROUGH AND THE DEVICE WAS REPLACED. THE CUSTOMER CONFIRMED THAT NO PIECES OF THE DEVICE FELL OFF INTO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773366 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE FELL OFF INSIDE THE PATIENT. THE PIECE WAS RETRIEVED WITHOUT NEEDING AN X-RAY TO LOCATE IT OR NEEDING A LARGER INCISION TO RETRIEVE IT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN FIVE MINUTES TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713696 ↗
• MalfunctionJun 9, 2020Melted; Melted

  IT WAS REPORTED THE HARMONIC SCALPEL (HARH45) BLADE COVER MELTED DURING THE PROCEDURE. NO PIECES FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE DURATION OF EXTENDED PROCEDURE TIME, HOWEVER NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136195 ↗
• MalfunctionMar 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE ULTRASONIC SCALPEL BROKE OFF DURING THE PROCEDURE INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING PROCEDURE AND NO ADDITIONAL PROCEDURE TIME WAS REQUIRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9803243 ↗
• MalfunctionJan 9, 2020Break; Break

  IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE HARMONIC ACE +7 SHEARS BLADE HAD BROKEN OFF AND FELL INTO THE PATIENT. NO HARM OCCURRED AND ALL PIECES WERE RETRIEVED WITH A GRASPER. A LARGER INCISION WAS NOT NEEDED FOR RETRIEVAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571914 ↗
• InjuryDec 23, 2019Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, SURGEON USED HARMONIC SCALPEL TO TAKE DOWN THE PENULTIMATE SHORT GASTRIC ARTERY. ADEQUATE COAPITATION DID NOT OCCUR, DESPITE THE HARMONIC ¿SENSING¿ THAT THE TISSUE WAS ADEQUATELY COAPTED. THE DIVIDED (BUT NOT HEMOSTATIC) SHORT GASTRIC ARTERY RETRACTED INTO THE SPLEEN, RETRIEVAL RESULTED IN A 2500ML BLOOD LOSS TO PATIENT AND REQUIRED REMOVAL OF SPLEEN AND TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS. PATIENT HAD AN EVENTFUL RECOVERY AND WAS DISCHARGED 24 HOURS POSTOPERATIVELY WITHOUT UNTOWARD SIGNS OR SYMPTOMS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9513175 ↗
• MalfunctionOct 23, 2019Break; Break

  IT WAS REPORTED THAT THE HARMONIC SCALPEL BLADE BROKE OFF INSIDE THE PATIENT. IT WAS RETRIEVED LAPAROSCOPICALLY, NO ADDITIONAL PROCEDURE NEEDED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227562 ↗
• InjurySep 19, 2019Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE PATIENT VESSEL SEAL STARTED TO LEAK INSIDE THE BARIATRIC PATIENT POST OPERATION. THE PATIENT WAS BROUGHT BACK INTO SURGERY FOR REPAIR AND WAS DISCHARGED WITHOUT FUTURE ISSUE. THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9087184 ↗
• InjuryJun 20, 2019Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE HARMONIC SCALPEL (HARH45) DID NOT PROPERLY SEAL ONE VESSEL AND CAUSED 1 LITER OF BLOOD TO BE LOST BY THE PATIENT. THE SIZE OF THE VESSEL IS UNKNOWN BY THE FACILITY BUT WAS SAID TO BE ONE VESSEL THAT THE SURGEON ALWAYS SEALS WITH THE DEVICE. THE FACILITY CONTACT IS NOT AWARE OF ANY FURTHER MEDICAL INTERVENTION. THE EXTENDED PROCEDURE TIME REPORTED WAS 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 8719408 ↗
• DeathMay 9, 2019Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE HARMONIC SCALPEL (HARH45) FAILED, IT WAS NOT SEALING PROPERLY. THIS WAS NOTED POST OPERATION. IT WAS STATED THE VESSEL WAS FULLY SEALED DURING THE BARIATRIC PROCEDURE, THE PATIENT WAS RELEASED, BUT CAME BACK AND THE VESSEL WAS BLEEDING AND THE PATIENT EXPIRED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss; Death

  MAUDE report 8597918 ↗
• InjuryApr 25, 2019Energy Output Problem; Energy Output Problem

  DURING A BARIATRIC CASE, IT WAS REPORTED THE HARMONIC SCALPEL (HARH45) GAVE A "HIGH PRESSURE" READING ON THE GENERATOR. THE DEVICE WAS REPLACED. THE PATIENT THEN CAME BACK INTO SURGERY DUE TO INTERNAL BLEEDING AN HOUR OR TWO LATER. THE PATIENT WAS BROUGHT BACK FOR TWO SEPARATE OPEN PROCEDURES AFTER THE ORIGINAL PROCEDURE, APPROXIMATELY 7 LITERS OF BLOOD WERE LOST ACCORDING TO ANESTHESIA. THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS. IT IS UNKNOWN BY THE FACILITY CONTACT IF THERE WILL BE ADDITIONAL FOLLOW-UP. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 8553239 ↗
• InjuryApr 25, 2019Energy Output Problem; Energy Output Problem

  DURING A BARIATRIC CASE, IT WAS REPORTED A PIECE OF BLADE FELL OFF THE HARMONIC SCALPEL (HARH45) INTO THE PATIENT. THE PIECE WAS RETRIEVED WITHOUT REQUIRING X-RAY NOR OPEN PROCEDURE. THE DEVICE WAS REPLACED. THE PATIENT THEN CAME BACK INTO SURGERY DUE TO INTERNAL BLEEDING AN HOUR OR TWO LATER. THE PATIENT WAS BROUGHT BACK FOR TWO SEPARATE OPEN PROCEDURES AFTER THE ORIGINAL PROCEDURE, APPROXIMATELY 7 LITERS OF BLOOD WERE LOST ACCORDING TO ANESTHESIA. THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS. IT IS UNKNOWN BY THE FACILITY CONTACT IF THERE WILL BE ADDITIONAL FOLLOW-UP. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 8553221 ↗
• MalfunctionApr 18, 2019Failure to Cut; Audible Prompt/Feedback Problem; Failure to Cut; Audible Prompt/Feedback Problem

  IT WAS REPORTED THE HARMONIC STOPPED CUTTING AND GENERATOR STARTED TO MAKE BEEPING SOUND. IT IS UNKNOWN BY THE FACILITY IF THERE WERE ANY ERROR CODES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8530005 ↗