Harmonic SynergyRecalls & reported problems across all models

We found 3 models of Harmonic Synergy by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2017 and Jun 26, 2026 — classified as 12 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Material Separation” (53 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 Synergy problems

Harmonic Synergy models

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

• Harmonic Synergy SNGHK

  Instrument, ultrasonic surgical
  61 reports
• Harmonic Synergy SNGCB

  Instrument, ultrasonic surgical
  50 reports
• Harmonic Synergy SNGHK2

  Instrument, ultrasonic surgical
  13 reports

Recent Harmonic Synergy adverse event reports

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

• MalfunctionJun 26, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING A CORONARY ARTERY BYPASS GRAFTING THE ¿RELAX PRESSURE ON BLADE¿ WAS DISPLAYED IN THE MIDDLE OF USE. THE PROBLEM DID NOT IMPROVE EVEN AFTER SETTING IT AGAIN, AND ¿REPLACE INSTRUMENT¿ WAS DISPLAYED IN THE END. THE SAME PROBLEM OCCURRED IN THE MIDDLE OF USE EVEN AFTER REPLACING IT WITH A NEW ONE, SO IT WAS SWITCHED TO A NEW HANDPIECE, THE SITUATION WAS NOT CHANGED. A THIRD HANDPIECE AND A THIRD DISPOSAL DEVICE WERE TAKEN OUT. AFTER THAT THE PROBLEM DID NOT OCCUR. 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 25636637 ↗
• MalfunctionJun 24, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, ¿TWO SWITCH ACTIVATIONS DETECTED¿ WAS DISPLAYED DURING CONNECTING. THE DEVICE WAS NOT USED FOR THE PATIENT. GEN11 WAS USED. THE NUMBER OF REMAINING USES WAS UNKNOWN. 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 25611068 ↗
• MalfunctionJun 1, 2026Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ACDF PROCEDURE, THE TIP WAS BENT WITH GENERATOR SAYING LOCKED INSTRUMENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351773 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KANANI F, KOZIN M, BEN AVRAHAM Y, AVITAN E, GUREVICH M, NESHER E, GRAVETZ A. LAPAROSCOPIC LIVING DONOR NEPHRECTOMY: LEARNING CURVE ANALYSIS THROUGH 1446 CASES AND OUTCOMES FROM 200 CONSECUTIVE MASTERY-PHASE PROCEDURES-HOW I DO IT. J CLIN MED. 2026 FEB 9;15(4):1363. DOI: 10.3390/JCM15041363. PMID: 41753051; PMCID: PMC12941911. THE AIM OF THIS STUDY IS TO HIGH-VOLUME SINGLE-CENTER EXPERIENCE WITH STANDARDIZED TRANSPERITONEAL LAPAROSCOPIC DONOR NEPHRECTOMY AND CUSUM-BASED LEARNING CURVE ANALYSIS. BETWEEN JANUARY 2015 AND DECEMBER 2024, A TOTAL OF 200 CONSECUTIVE LAPAROSCOPIC LIVING DONOR NEPHRECTOMIES WERE USING ETHICON ENDOPATH, ETHICON HARMONICACE® + SHEARSORHARMONIC SYNERGY® HOOK, ETHICON LIGACLIP®, ETHICON ECHELONFLEX¿, SURGICEL® ETHICON, 0-VICRYL, 4-0 MONOCRYL AND DERMABOND® (ETHICON). REPORTED COMPLICATIONS ARE N=8; CLAVIEN¿DINDO (GRADE I) TREATMENT: NOT MENTIONED N=3; CLAVIEN¿DINDO (GRADE II) TREATMENT: NOT MENTIONED N=1; CLAVIEN¿DINDO (GRADE=III) TREATMENT: NOT MENTIONED N=2; SUPERFICIAL SSI TREATMENT: NOT MENTIONED N=1; SEROMA TREATMENT: NOT MENTIONED N=1; INTRA-ABDOMINAL COLLECTION T

  Patient problems: Insufficient Information; Pain; Post Operative Wound Infection; Seroma; Urinary Retention

  MAUDE report 24712788 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ANTERIOR SPINAL FUSION, THE BLADE WAS BROKEN DURING USE. GEN11 WAS USED. THE NUMBER OF REMAINING USES OF HPBLUE WAS 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 23850385 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE TIP WAS BROKEN. THERE WAS NO EFFECT ON 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 23732819 ↗
• MalfunctionAug 8, 2025Failure to Read Input Signal; Material Integrity Problem; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT, DURING OPEN CARDIOVASCULAR PROCEDURE, WHEN THE SOFT TISSUE OF PLEURAL ADHESIONS WAS CUTTING, A MESSAGE LIKE ¿RELAX PRESSURE ON BLADE¿ WAS DISPLAYED, SO THE HOSPITAL CONFIRMED IT OUTSIDE OF THE OPERATIVE FIELD, THE HOSPITAL CONFIRMED THE CRACK. NO PIECES WERE FELL INTO THE PATIENT. GEN11 WAS USED. THE NUMBER OF REMAINING USES OF HPBLUE WAS UNKNOWN. 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 22750390 ↗
• InjuryJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  TITLE: A COMPARATIVE STUDY OF COLD DISSECTION TONSILLECTOMY AND HARMONIC SCALPEL TONSILLECTOMY UNDER MICROSCOPE - OUR EXPERIENCE AUTHORS: SUNIL KUMAR SAMDANI, JUGAL KISHORE, VIPASHA YOGI, SANJAY SHARMA, AMREEN. CITATION CITE: (DECEMBER 2022) 74(SUPPL 3):S5395¿S5403; HTTPS://DOI.ORG/10.1007/S12070-021-02586-W. THE AIM OF THIS PROSPECTIVE COMPARATIVE STUDY IS TO COMPARE DIFFERENT VARIABLES SUCH AS TONSILLECTOMY TIME, INTRAOPERATIVE BLOOD LOSS, POST OPERATIVE PAIN AND WOUND HEALING WITH THE TWO METHODS (HARMONIC SCALPEL AND COLD DISSECTION) UNDER MICROSCOPIC VISUALISATION TO SELECT THE BEST METHOD ACCORDING TO THE PATIENT¿S CONDITION. FROM JULY 2019 TO JUNE 2020, A TOTAL OF 40 CASES WITH AGES BETWEEN 4¿14 YEARS (MEAN AGE OF 8 YEARS IN WHICH 31 WERE MALES AND 9 WERE FEMALES) DIAGNOSED AS ADENO-TONSILLAR HYPERTROPHY OF GRADE 3-4 WERE STUDIED. AGE AND GENDER DISTRIBUTION HAS NO EFFECT IN COMPARISON OF OUTCOMES AS EACH PATIENT UNDERWENT TONSILLECTOMY BY COLD DISSECTION METHOD ON ONE SIDE AND BY ULTRASONIC SCALPEL ON OTHER AND THIS WAS DECIDED BY ODD EVEN METHOD OF RANDOMIZATION. MICROSCOPE WAS USED FOR TONSILLECTOMY ON EITHER SIDE. IN COLD DISSECTION METHOD DONE BY EVE¿S TONSILLAR SNARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Pain

  MAUDE report 22370845 ↗
• MalfunctionMay 12, 2025Failure to Read Input Signal; Failure 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 22002407 ↗
• MalfunctionFeb 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING OPEN CONIZATION, THE TIP OF THE DEVICE WAS BROKEN. NO PIECES WERE FELL INTO 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 21411877 ↗
• MalfunctionSep 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CABG PROCEDURE THE TIP OF THE BLADE BROKE SUDDENLY WITHOUT ANY EXTERNAL CONTACT. FRAGMENTS WERE GENERATED BUT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. OPENED A NEW PROBE. THE PROCEDURE WAS DELAYED 15-20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182127 ↗
• MalfunctionMay 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY A BROKEN BLADE. NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234570 ↗
• MalfunctionMar 13, 2024Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING OPEN CORONARY ARTERY BYPASS GRAFTING, AN UNKNOWN ERROR OCCURRED WHEN THE DEVICE WAS USED ON BLOOD VESSELS. WHEN THE DEVICE WAS CLEANED AND CHECKED OUT OF THE BODY, THE BLADE WAS BROKEN. 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 18893758 ↗
• MalfunctionFeb 9, 2024Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING OMENTUM PATCH REPAIR, WHEN THE DEVICE WAS USED TO DETACH ADHESIONS, THE TIP OF THE DEVICE WAS BROKEN, AND AN UNKNOWN ERROR OCCURRED. THE BROKEN FRAGMENT WAS REMOVED AND WILL BE RETURNED. THERE WAS NO BLEEDING. 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 18675478 ↗
• MalfunctionJan 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, SNGCB WAS FOUND IN THE PACKAGE OF SNGHK. SNGHK WAS REGISTERED IN COMPLAINT, BUT THE ACTUAL RETURNED PRODUCT IS SNGCB. 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 18595864 ↗

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