N/A (REF HARH36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 07613327346251), received between May 26, 2017 and Feb 26, 2026 — classified as 13 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 19, 2021Open, Classified

   Product was distributed without receiving regulatory clearance.

   Z-1327-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A LAPAROSCOPIC OVARIAN CYSTECTOMY AND AFTER REMOVAL OF THE CYST, THE SURGEON INSPECTED THE PELVIS AND ABDOMEN AND NOTED A SMALL BOWEL DEFECT WITH OOZING <0.5MC IN SIZE. GENERAL SURGERY CALLED INTO CASE AND PERFORMED A SEROSA CLOSURE WITH 4 SUTURES, NO FURTHER COMPLICATIONS. PATIENT RECOVERED AND DISCHARGED HOME. SURGEON BELIEVED THE HARMONIC STAYED HOT WHEN NOT ACTIVATED. 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: Bowel Burn; Insufficient Information

  MAUDE report 24459123 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HARMONICS ARE SHOWING GENERATOR ERROR CONSISTENT WITH: RELAX PRESSURE ON BLADE, THEN TELLS TO REMOVE DEVICE FROM THE PATENT. THE GENERATOR SHOWS NO INSTRUMENT USES REMAINING. THE DEVICE WILL NOT DO THE INITIAL SET UP WITH THE GENERATOR. THE DEVICE STOPS FUNCTIONING. CUSTOMER HAD TO CLAMP A LARGE ARTERY FOR EXTENDED TIME DUE TO PRODUCT FAILURES AND TIME TO GET A FUNCTIONING DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 20 MINUTES TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599453 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A HARH36 IS DEFECTIVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562225 ↗
• MalfunctionJan 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE JAW SNAPPED IN HALF DURING THE PROCEDURE. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162116 ↗
• MalfunctionJan 7, 2025Material Fragmentation; Compatibility Problem; Material Fragmentation; Compatibility Problem

  IT WAS REPORTED THAT THE CONSOLE STATED THE DEVICE WAS EXPIRED OR HAD NO MORE TURNS LEFT. AS REPORTED, THE JAW BLADE WAS INTACT FOR THIS ITEM PRIOR TO SHIPPING. 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 21095974 ↗
• MalfunctionNov 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BLADE TIP BROKE OFF INSIDE OF THE PATIENT. AS REPORTED, THE TIP WAS RETRIEVED USING A GRASPER AND A LARGER INCISION WAS NOT MADE. THERE WAS NO PATIENT INJURY, NO OTHER 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 20787786 ↗
• MalfunctionOct 7, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE THE JAWS BROKE BUT WERE RETRIEVED DURING THE CASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391499 ↗
• MalfunctionJul 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HARMONIC WAS BEING USED AND BROKE DURING SURGERY. 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 19832842 ↗
• MalfunctionApr 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE JAW FELL OFF THE COMPLAINT DEVICE DURING THE CASE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. 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 19190810 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE IN USE, ONE OF THE DEVICE'S GRASPING ENDS BROKE OFF INTO THE PATIENT. IT WAS ALSO REPORTED THAT THE PIECE WAS RETRIEVED WITHOUT INTERVENTION, THE DEVICE WAS REPLACED, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 18739169 ↗
• MalfunctionJan 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE'S TIP BROKE OFF WHEN STAFF WENT TO USE THE DEVICE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540889 ↗
• InjuryJun 21, 2023Fracture; Fracture

  IT WAS REPORTED THE LOWER METAL JAW OF THE DEVICE SNAPPED OFF WHEN THE DOCTOR WAS REMOVING THE DEVICE AND THE PIECE OF METAL WAS LOST IN THE PATIENT FOR OVER 30 MINUTES. SEVERAL X-RAYS WERE DONE DURING THE PROCEDURE TO IDENTIFY AND RECOVER THE LOST PIECE. THERE WAS NO ADDITIONAL PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE EXTENDED PROCEDURE TIME WAS 30 MINUTES. THE COMPLAINT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17174927 ↗
• MalfunctionMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THE DEVICE BROKE OFF INSIDE THE PATIENT DURING A THORACOSCOPIC DECORTICATION ON APRIL 28TH. THE DISLODGED PIECE WAS SUCCESSFULLY RECOVERED AND SHIPPED BACK. THERE WAS NO ADDITIONAL PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINANT IS NOT AWARE OF THE EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989348 ↗
• MalfunctionMay 9, 2023Fracture; Fracture

  IT WAS REPORTED THE BLADE OF THE DEVICE BROKE INSIDE THE PATIENT AND THAT THE PIECE WAS RECOVERED MANUALLY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 16898794 ↗
• MalfunctionApr 4, 2023Fracture; Fracture

  IT WAS REPORTED THE TIP CAME OFF AT THE END OF SURGERY AND FELL ONTO THE DRAPE. THE DEVICE WAS REMOVED FROM THE FIELD AND BAGGED FOR PICK UP. 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 16677729 ↗
• MalfunctionFeb 13, 2023Crack; Crack

  IT WAS REPORTED THE HARMONIC ACE 7 SHEARS DISPOSABLE HANDPIECE STOPPED WORKING DURING LAPAROSCOPIC HYSTERECTOMY. CRACKS WERE NOT VISIBLE OR IDENTIFIED PRIOR TO USE. THE UNIT WAS SENT TO CLINICAL ENGINEERING TO EVALUATE FOR ANY POSSIBLE ISSUES. CLINICAL ENGINEERING TESTED THE HARMONIC UNIT, AND IT IS FUNCTIONING PROPERLY. THEY WERE ABLE TO REVIEW THE MACHINE'S ISSUE HISTORY, WHICH SHOWS THE MOST RECENT ISSUES WERE DUE TO THE DISPOSABLE HANDPIECE TIP HAVING A CRACK. THE HANDPIECE WAS CHANGED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY 10-15 MINUTES TO GET ADDITIONAL HANDPIECES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362818 ↗
• MalfunctionDec 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT A STRYKER DEVICE WAS SENT TO CG LABS (ETHICON). THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15894087 ↗
• MalfunctionNov 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE HARMONIC DEVICE BROKE WHILE IN USE. ALL PARTS WERE RETRIEVED, AND THE DEVICE WAS REPLACED. THE SURGEON WAS UTILIZING THE HARMONIC AROUND THE METAL KOH UTERINE MANIPULATOR, WHICH MAY HAVE IMPACTED THE INTEGRITY OF THE HARMONIC. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15852537 ↗
• InjuryOct 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A HARH36 WAS NOT SEALING PROPERLY. IT WAS REPORTED THAT, DUE TO BLEEDING, THE SURGEON HAD TO GO FROM LAPAROSCOPIC TO OPEN PROCEDURE. AN INJURY TO THE PULMONARY VEIN WAS ALSO REPORTED. HOWEVER, THE SURGEON STATED THIS INJURY WAS NOT CAUSED BY THE DEVICE IN QUESTION. THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15598269 ↗
• InjuryOct 11, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE HARH36 DID NOT WORK ON THE PATIENT. THERE WERE SEVERAL ERROR CODES AFTER USING TWO MACHINES. THEY TRIED TROUBLESHOOTING, BUT THE DOCTOR DECIDED NOT TO PERFORM A LAPAROSCOPIC PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY ADVERSE CONSEQUENCES OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583732 ↗
• InjuryOct 11, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE HARH36 DID NOT WORK ON THE PATIENT. THERE WERE SEVERAL ERROR CODES AFTER USING TWO MACHINES. THEY TRIED TROUBLESHOOTING, BUT THE DOCTOR DECIDED NOT TO PERFORM A LAPAROSCOPIC PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY ADVERSE CONSEQUENCES OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583142 ↗
• MalfunctionAug 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED FOR HARH36 HARMONIC DEVICE "DURING SURGERY, THE TIP PEELED OFF. THE TEFLON PAD HAD BECOME DISLODGED. THE DEVICE WAS USED CLINICALLY, AND THE PAD DID NOT FALL OFF INTO THE PATIENT". THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 15184592 ↗
• MalfunctionApr 4, 2022Fracture; Fracture

  THE TIP OF A HARMONIC SCALPEL WAS REPORTED BROKEN DURING PROCEDURE. 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 13997666 ↗
• MalfunctionFeb 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THERE WAS MELTED PLASTIC ON THE TIP OF THE SHEARS AND THE DEVICE WAS REPLACED TO FINISH THE CASE. 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 13607794 ↗
• MalfunctionDec 3, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE HARMONIC DEVICE WAS DEFECTIVE. 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 12929618 ↗