Harmonic HAR736Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705036035770), received between Jun 26, 2024 and Sep 28, 2026 — classified as 3 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Material Separation” (37 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Delivered as Unsterile Product

  It was reported that the packaging was open. It was set aside and a new device was used. There was no patient consequence reported. There was a 5 minute delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914140 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported that during a TAH procedure the blade broke. No patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882741 ↗
• MalfunctionSep 23, 2026Material Separation

  It was reported that during an unknown procedure the tip of the Harmonic fell off. Attempted to find it and patient had to go for X ray to find it. No patient consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866601 ↗
• MalfunctionSep 9, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696019 ↗
• MalfunctionJun 29, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SHEARS BROKE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652928 ↗
• MalfunctionJun 29, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP OF DEVICE BROKE OFF INSIDE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652842 ↗
• InjuryJun 18, 2026Failure to Read Input Signal

  IN CARDIAC THEATRE TODAY, WE HAVE HAD ISSUES WITH USING THE HARMONIC AND CONNECTING IT ON THE MACHINE. WE TRIED A FEW TIMES WITH TROUBLESHOOTING IT BUT HALFWAY THROUGH THE PROCEDURE, IT HAD AN ERROR AGAIN SAYING, 'TIGHTEN ASSEMBLY' WHEN IN FACT IT WAS WORKING FINE INITIALLY AND WAS TESTED BEFORE USE. UNFORTUNATELY, OUR CONSULTANT SURGEON ENDED UP JUST MANUALLY HARVESTING THE MAMMARY ARTERY BY OPENING THE PATIENT THROUGH THORACOTOMY.

  Patient problems: Insufficient Information

  MAUDE report 25549495 ↗
• MalfunctionJun 11, 2026Difficult or Delayed Activation; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TOTAL COLECTOMY PROCEDURE THE DEVICE WAS USED FOR ABOUT 3 HOURS, WITH A CORRECT INITIAL OPERATION (NO ALARM OR ERROR MESSAGE, USUAL NOISE). DURING THE INTERVENTION, THE OPERATOR NOTICED THAT THE CLAMP WAS NO LONGER WORKING. IT WAS REMOVED FROM THE OPERATING FIELD TO BE CLEANED BY THE INSTRUMENTALIST. DURING HANDLING, ONE OF THE JAWS OF THE CLAMP FRACTURED IN HALF, WITHOUT EXERTING EXCESSIVE CONSTRAINTS. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469567 ↗
• MalfunctionJun 9, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A "RELEASE JAWS" ERROR MESSAGE - CLAMP CLEANED AND TESTED: MESSAGE AGAIN - HANDPIECE TEST AND CHANGE - ERROR MESSAGE. THE SURGERY COMPLETED WITHOUT CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445387 ↗
• MalfunctionMay 26, 2026Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT AT THE END OF THE UNKNOWN SURGERY, THE FORCEPS MALFUNCTIONED. WE CHANGED THE HANDPIECE AND EVEN SO IT HAD A DEFECT AND IN THE ACT OF DOING THE TEST AGAIN THE TIP OF THE CALIPER HAD BROKEN BUT THE TEAM DID NOT NEED TO OPEN ANOTHER CALIPER. AS SOON AS THE TWEEZERS STOPPED, HE PRESENTED HIMSELF TO RESTART, WE DID THE TEST AND APPEARED, I PRESSED AND I GOT IT. ONCE THIS WAS DONE, WE PROVIDED ANOTHER FORCEPS, BUT THE MEDICAL TEAM NO LONGER NEEDED THE FORCEPS, SO A NEW ONE WAS NOT OPENED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280131 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGICAL PROCEDURE FOR EXCISION OF ENDOMETRIOSIS AND LEIOMYOMA FOCI, THE HARMONIC ULTRASONIC DEVICE (MODEL HAR736, ETHICON) WAS USED. DURING THE SURGICAL PROCEDURE, A CHANGE IN THE SOUND PATTERN OF THE EQUIPMENT WAS OBSERVED DURING ACTIVATION, FOLLOWED IMMEDIATELY BY MECHANICAL FAILURE CHARACTERIZED BY THE COMPLETE DETACHMENT OF THE ACTIVE DISTAL PORTION OF THE FORCEPS (MANDIBLE/JAW). THE DETACHED PART CORRESPONDS TO THE FUNCTIONAL END (BLACK COMPONENT OF THE FORCEPS), HAVING BEEN FULLY RELEASED INTO THE ABDOMINAL CAVITY, WITHOUT APPARENT FRAGMENTATION. THE SPECIMEN WAS PROMPTLY IDENTIFIED AND REMOVED DURING THE PROCEDURE, WITH NO EVIDENCE OF FRAGMENT RETENTION IN THE PATIENT. THE PROCEDURE WAS CONTINUED AFTER REPLACEMENT OF THE DEVICE, WITH NO OTHER COMPLICATIONS RELATED TO THE EVENT DESCRIBED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966601 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLAMP BLADE BROKE DURING USE IN THE PATIENT'S TUMMY. INABILITY TO USE THE CLAMP + RISK OF LOSING THE BLADE IN THE PATIENT'S TUMMY. REMOVE THE BLADE AND CHANGE THE HARMONIC CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957659 ↗
• MalfunctionApr 14, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER SHORT TERM ACTIVATION, STOPPED WITH CLEAN LEMMET. AFTER CLEANING LEMMET IT STILL DOESN'T WORK. THEY TOOK A NEW HAR736. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877486 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PATIENT'S UNKNOWN SURGERY. THE BRANCH BROKE OFF DURING A COAGULATION PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734787 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE IN A LAPAROSCOPIC HYSTERECTOMY THE ACTIVE BRANCH OF DEVICE (THE TITANIUM ONE) HAS SNAPPED/CHIPPED AT THE TIP. IT HAPPENED AT THE END OF THE PROCEDURE. THE OPERATOR NOTICED THIS AND WAS ABLE TO RETRIEVE THE PIECE THAT HAD ENDED UP IN THE DOUGLAS. THE PATIENT IS FINE AND HAS NOT BEEN IMPACTED. THE INSTRUMENT HAD NO APPARENT TRAUMA; NO METAL CLIP GRIP. IT IS PROBABLY THOUGHT THAT IT MAY HAVE BEEN HAVING HIT THE WALLS OF THE TROCAR. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717288 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE SCISSORS BROKE OFF. SO IT WAS NECESSARY TO SEARCH FOR THE BROKEN PIECE IN THE OPERATING SITE FOR A LONG TIME. THERE WERE NO PATIENT CONSEQUENCES.

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

  MAUDE report 24716302 ↗
• MalfunctionMar 13, 2026Material Separation

  IT WAS REPORTED THAT THE ACTIVE BLADE BROKE OFF DURING ACTIVE USE. SURGEON WAS CUTTING THROUGH THE OUTER LAYER OF A FIBROID DURING A MYOMECTOMY WHEN THE BLADE BROKE OFF THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590966 ↗
• MalfunctionMar 3, 2026Material Separation

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC HYSTERECTOMY, A METAL UTERINE MANIPULATOR WAS USED AND IT CAME WHEN THE HARMONIC BLADE WAS WORKING TOWARDS THE METAL UTERINE MANIPULATOR. THE BLADE OF THE HARMONIC BROKE OFF INTO PATIENT'S BELLY. THE BLADE WAS RETRIEVED FROM THE CAVITY WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500113 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT THE JAW BROKE DURING RECTOVAGINOPEXY. GENERATOR GAVE AN ERROR ONCE DURING THE PROCEDURE. JAW BROKE INSIDE THE PATIENT; THE FRAGMENT COULD BE RECOVERED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379727 ↗
• MalfunctionFeb 4, 2026Material Separation

  IT WAS REPORTED THAT DURING A COLPOTOMY THE SCALPEL BLADE SNAPPED OFF INSIDE PATIENT BUT WAS RECOVERED BY THE PHYSICIAN IMMEDIATELY AND REMOVED FROM THE STERILE FIELD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261027 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT DURING THE RESECTION LIVER PROCEDURE, THE BLADE BROKE INSIDE THE ABDOMEN. THE BLADE WAS RETRIEVED. DEVICE REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095010 ↗
• MalfunctionJan 9, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW BROKE DURING THE ACTIVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019570 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT THE ACTIVE BLADE BROKE OFF IN THE PATIENT DURING A TLH. THERE WAS NO HARM TO THE PATIENT. ANOTHER DEVICE WAS OPENED TO COMPLETE THE REST OF THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975912 ↗
• MalfunctionDec 17, 2025Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE BLADE OF THE DEVICE BROKE OFF. THERE WERE NO PATIENT ADVERSE EVENT. THERE WERE ERROR MESSAGES. THEY GOT MESSAGE RELAX THE PRESSURE OF HE BLADE. THEY REMOVED THE PRODUCT AND THEN THEY UNPLUG THE PRODUCT FROM THE GENERATOR. ONCE THEY PLUG IT BACK IN, THEY GOT NEW MASSAGE FROM THE GENERATOR IT SAYS TIGHTEN ASSEMBLY AND RETEST THE HARMONIC. ONCE THEY RETEST IT THEY PUT IT BACK TO THE PATIENT AND NOTICE THE BLADE WAS MISSING. THEY WERE LOOKING FOR THE BLADE AND FOUND IT OUTSIDE OF THE PATIENT-ON-PATIENT ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827352 ↗
• MalfunctionNov 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TLH THE ACTIVE BLADE BROKE OFF. HOWEVER, IT WAS RECOVERED, NO PARTS REMAIN IN PATIENT. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510923 ↗