Harmonic HAR723Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705036035763), received between Mar 19, 2025 and Apr 28, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT THE DEVICE STOPPED WORKING MID CASE, USE OF OUR OWN CABLE, ATTEMPTED TO RESTART AND CHECK DEVICE. ONCE RESTARTED BLADE WAS NO LONGER GOOD, NEW DEVICE WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019610 ↗
• MalfunctionFeb 24, 2026Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A HEPATECTOMY THE DEVICE SUCCESSFULLY PASSED THE PREOPERATIVE TEST. AT SOME POINT THE SURGEON ACTIVATED THE DEVICE AND THE GENERATOR DISPLAYED THE MESSAGE RELEASE PRESSURE ON BLADES. HE THEN NOTICED THAT THE ACTIVE BLADE WAS BROKEN. THE SURGEON REPLACED THE DEVICE WITH ANOTHER HAR723 AND REMOVED THE BROKEN BLADE, AFTER WHICH THE PROCEDURE PROCEEDED WITHOUT FURTHER COMPLICATIONS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431242 ↗
• MalfunctionJan 14, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A PANCREAS PROCEDURE OPEN THE GENERATOR DISPLAYED THE MESSAGE "NO MORE INSTRUMENT INSERTIONS REMAINING - REMOVE AND REPLACE INSTRUMENT." IT WAS NO LONGER POSSIBLE TO CONTINUE WORKING WITH THE SCISSORS. THEY USED A NEW ONE (WITH THE SAME HARHPGR) AND PROCEDURE COULD FINISHED SUCCESSFULLY. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067539 ↗
• InjuryJul 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL (B)(4) LOWER GASTROINTESTINAL PROCEDURE THE PATIENT EXPERIENCED A PELVIC HAEMATOMA. THE PATIENT REQUIRED DIAGNOSTIC IMAGING - CT ANGIO, DRUG THERAPY, AND A BLOOD TRANSFUSION. THEY ALSO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. THE ADVERSE EVENT HAS A POSSIBLE RELATIONSHIP WITH BOTH THE DEVICE AND STUDY PROCEDURE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22674316 ↗
• MalfunctionJul 15, 2025Material Separation; Failure to Read Input Signal; Material Integrity Problem; Material Separation; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY, AHEAD OF THE DAMAGE OF THE BLADE, THE GEN11 SHOWED PLEASE RELEASE PRESSURE ON BLADE. DURING CLEANING OF THE BLADE, IS BROKE APART. THE SURGEONS COMMUNICATED, THAT THEY HAVEN HAD PUT A LOT OF PRESSURE ON THE BLADE. THE FAILURE MESSAGES AND THE DAMAGE OF THE BLADE OCCURRED DURING THE LYMPHADENECTOMY. NORMALLY THEY ARE NOT PUTTING A LOT OF PRESSURE ON THE BLADE. REPLACED BY ANOTHER INSTRUMENT. 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 22511542 ↗
• MalfunctionMar 31, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN ESOPHAGUS PROCEDURE THE SCISSORS COULD NO LONGER BE ACTIVATED IN THE OPEN PART OF THE SURGERY AFTER A SHORT TIME. REDUCE PRESSURE ON THE BLADE, REMOVE THE INSTRUMENT FROM THE PATIENT. THE GENERATOR DISPLAYED: REPLACE INSTRUMENT - INSTRUMENT ERROR DETECTED. NO PATIENT HARM OR SURGICAL DELAY HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734024 ↗
• InjuryMar 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A RECTOCOLECTOMY, ROBOT CONVERTED TO LAPARO THE CLAMP DOES NOT WORK ON THE GENERATOR. TAKING AN ULTRACISION OF ANOTHER BRAND TO OPERATE. LOSS OF CHANCE FOR THE PATIENT BECAUSE THE SURGEON HAD TO OPERATE WITH EQUIPMENT OF THE WRONG SIZE FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21642066 ↗