N/A HAR1120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327586565), received between Oct 31, 2024 and Nov 13, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HARMONIC MALFUNCTIONED DURING THE OPERATION WHILE IN USE. THE SURGEON NOTICED THE HARMONIC WAS NOT WORKING AND THE OPERATING ROOM RN CHECKED THE GENERATOR MACHINE WHERE IT HAD STEP BY STEP INSTRUCTIONS. THE OPERATING ROOM RN HAD THE ST REMOVE THE DEVICE FROM USE, CLEAN THE JAWS, AND THE MACHINE DID ANOTHER TEST. THE GENERATOR FLASHED ORANGE AND SAID A REPLACEMENT WAS NEEDED. THE OPERATING ROOM RN TRIED UNPLUGGING THE SAME INSTRUMENT AND RE-PLUGGING IT IN TO SEE IF THAT WOULD DO ANYTHING AND IT STILL A REPLACEMENT WAS NEEDED. AS REPORTED, A NEW HARMONIC WAS OPENED AND THE MALFUNCTIONED HARMONIC WAS TAKEN OFF OF THE FIELD. 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 23550240 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HARMONIC DEVICE KEPT FIRING WHEN IT WAS NOT BEING ACTIVATED AND THE ACTIVATION TONE WAS HEARD WHILE NOT IN USE. AS REPORTED, STAFF RESET THE GENERATOR AND RE-PLUGGED IN THE DEVICE AND IT WAS STILL NOT WORKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663546 ↗
• MalfunctionMar 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BLADE BROKE WHILE CUTTING LIVER TISSUE. AS REPORTED, THE DEVICE WAS REPLACED WITH A STRYKER DEVICE. PER THE SALES REPRESENTATIVE, THE BLADE WAS RECOVERED IN FULL, THE PROCEDURE WAS NOT ALTERED IN ANY WAY, AND NO IMAGING WAS USED POST CARE GIVEN THE BLADE WAS FULLY RECOVERED. 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 21516172 ↗
• InjuryOct 31, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TIP OF THE BLADE BROKE OFF DURING THE PROCEDURE INSIDE OF THE PATIENT AND COULD NOT BE RECOVERED. AS REPORTED, X-RAYS WERE USED TO LOCATE THE TIP WITHIN THE BODY CAVITY BUT IT WAS NOT RETRIEVED. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND EXTENDED PROCEDURE TIME REPORTED WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582623 ↗