Harmonic FocusRecalls & reported problems across all models

We found 3 models of Harmonic Focus by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 388 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2017 and Sep 21, 2026 — classified as 1 death, 42 injuries, 345 malfunctions.

The most frequently reported specific device problem is “Material Separation” (123 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Harmonic Focus problems

Harmonic Focus models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Harmonic Focus HAR9F

  Instrument, ultrasonic surgical
  1 death371 reports
• Harmonic Focus FCS17

  Instrument, ultrasonic surgical
  9 reports
• Harmonic Focus FCS9

  Instrument, ultrasonic surgical
  8 reports

Recent Harmonic Focus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841901 ↗
• InjuryAug 6, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that during a thyroidectomy procedure, during usage, surgeon had complained that the device was not coagulating tissue well and ineffective in its function. Surgeon then decided to use another device to complete the surgery. Upon surgery completion, the patient was extubated. Upon extubating the patient, there was a bleeding incident originating from the surgical site. Decision was made to re-open the surgical site and investigate. Surgeon noticed that the bleeding was originated from the strep muscle and made a deduction that the bleeding was due to the HAR9F ineffectively sealing the strep muscle during the initial stage of surgery. Bleeding was controlled and patient was managed.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50165115 ↗
• MalfunctionJun 22, 2026Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN DENTAL AND ORAL SURGERY, THE BLADE WAS BROKEN. THE DETAILS OF THE ERROR ARE UNKNOWN. NO PIECES WERE LEFT INSIDE 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 25576586 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE SALES REP THAT, AFTER AN UNKNOWN ENT (EYES, NOSE, AND THROAT) SURGERY, POSTOPERATIVE BLEEDING OCCURRED, AND UPON PERFORMING REOPERATION, TREATMENT WAS PERFORMED. THE PATIENT HAS RECOVERED WITHOUT ANY PROBLEMS SINCE THE REOPERATION. THE SURGEON BELIEVES THE CAUSE OF THIS EVENT IS NOT A PROBLEM WITH THE INSTRUMENT, BUT RATHER THE ISSUE WAS IDENTIFIED AS BEING ON THE USER'S END. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25415673 ↗
• MalfunctionJun 4, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A MESSAGE THAT THERE WERE PRESSURE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394375 ↗
• MalfunctionMay 26, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE INITIAL DEVICE FAILED TO FUNCTION UPON FIRST USE. A SECOND DEVICE WAS OPENED AND UTILIZED; HOWEVER, IT CEASED FUNCTIONING APPROXIMATELY HALFWAY THROUGH THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR ADVERSE OUTCOMES ASSOCIATED WITH THE DEVICE FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279851 ↗
• MalfunctionMay 14, 2026Material Separation

  IT WAS REPORTED THAT DURING A NECK MASS EXCISION, THE SURGEON MENTIONED THAT THE DEVICE "DIDN'T FEEL RIGHT." WHILE SHE WAS WORKING, THE BLADE BROKE, THIS WAS RECOVERED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171353 ↗
• MalfunctionApr 28, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE TIP FRACTURE OCCURRED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017436 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP BROKE DURING USE, SO IT CANNOT BE USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874699 ↗
• MalfunctionMar 16, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS CONNECTED TO THE GEN11 AND DIRECTLY THE GEN INDICATED THE TIP/JAW WAS BROKEN. THE NEEDED TO CHANGE TO A NEW DEVICE AND THEN IT WORKED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605185 ↗
• MalfunctionFeb 6, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLADE WAS RECEIVED BROKEN AT THE TIME OF OPENING THE PACKAGE OF THE PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282237 ↗
• MalfunctionFeb 3, 2026Material Separation; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE THE TIP FELL OFF FROM THE DEVICE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250230 ↗
• MalfunctionJan 27, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS AN ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191008 ↗
• MalfunctionJan 22, 2026Material Separation

  IT WAS REPORTED THAT, DURING A LARYNGEAL CANCER SURGERY, THE BLADE WAS BROKEN DURING SURGERY, AND THE BROKEN BLADE WAS RETRIEVED FROM INSIDE THE PATIENT'S BODY. THE BLADE REMAINING IN THE DEVICE MATCHED THE BROKEN PART OF THE RETRIEVED BLADE. NO PIECES WERE LEFT INSIDE 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 24146671 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE UNPROTECTED TIP/JAW OF THE HANDPIECE BREAKS DURING THE PROCEDURE. THERE WAS UNCERTAINTY IN THE FUNCTIONING OF THE TIP COMPONENT AT THE BEGINNING OF THE PROCEDURE. TESTING WAS CARRIED OUT PROPERLY. RETESTING AND RESTART WERE DONE, AFTER WHICH IT WORKED NORMALLY. LATER, DURING NORMAL USE, THE TIP BROKE. FRAGMENTS WERE GENERATED BUT EASILY REMOVED WITHOUT ADDITIONAL INFORMATION. A NEW HANDPIECE WAS TAKEN INTO USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975777 ↗

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