Harmonic Synergy SNGCBRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705036002802), received between Jun 28, 2018 and Jun 1, 2026 — classified as 4 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 50 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE TIP OF THE BLADE WAS BROKEN AND THE TIP WAS LOOSEN OF THE BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484398 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE BROKE. THE BROKEN PIECES WERE RETRIEVED AND DISCARDED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852761 ↗
• MalfunctionAug 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLADE NO LONGER SEEMED TO BE WORKING PROPERLY. UPON CLOSER INSPECTION THE BLADE HAD SNAPPED INTO 2 PIECES. THE PIECE WHICH CAME OFF WAS LOCATED AND PUT TO ONE SIDE WITH THE REST OF THE BLADE. SECOND DEVICE OPENED AND NO FURTHER ISSUES OCCURRED FOR REMAINDER OF CASE. SURGEON DID ACKNOWLEDGE THAT HE MAY HAVE COME INTO CONTACT WITH BONE WHEN USING THE DEVICE, WHICH MAY HAVE BEEN THE CAUSE OF THE BLADE BREAKING. NO PATIENT IMPACT (SURGEON MADE NO COMPLAINT OF THIS AND NO FURTHER ISSUES OCCURRED WHEN SECOND DEVICE OPENED) AND ONLY A PAUSE OF 2-3 MINUTES WHILST OPENING SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549165 ↗
• MalfunctionJul 17, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE DEVICE DID NOT PASS THE TEST. GEN11 WAS USED. 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 17334886 ↗
• MalfunctionMar 28, 2023Failure to Read Input Signal; Difficult or Delayed Activation; Material Integrity Problem; Failure to Read Input Signal; Difficult or Delayed Activation; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS BEING USED TO AMPUTATE A CAT'S HIND LIMB. THE BLADE WAS WORKING WELL INITIALLY AND CUT THROUGH MULTIPLE MUSCLES. TOWARDS THE END OF THE PROCEDURE THE HANDPIECE MADE A BEEPING NOISE AND STOPPED CUTTING. THE MACHINE ERROR MESSAGE READ SOMETHING LIKE "REDUCE PRESSURE ON BLADE". I THEN INSPECTED THE BLADE AND COULD VISUALIZE A SMALL CRACK ON THE BLADE. THE USER HAD NOT KNOWINGLY MADE CONTACT WITH ANOTHER INSTRUMENT BUT THE BLADE COULD POTENTIALLY HAVE CONTACTED BONE (BUT NOT FOR A SUSTAINED PERIOD). I STOPPED USING THE BLADE AND MANAGED TO COMPLETE THE PROCEDURE WITHOUT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629495 ↗
• MalfunctionJan 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE PARTS WERE BROKEN WHEN THE DEVICE WAS CONNECTED WITH HANDPIECE BY TORQUE WRENCH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264128 ↗
• MalfunctionJan 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING CONIZATION, THE BLADE WAS BROKEN WITHOUT ANY ERROR SOUND DURING USE. THERE IS A POSSIBILITY THAT THE BROKEN PIECES FELL INTO THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140062 ↗
• MalfunctionMay 20, 2022Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN OPEN MYOMECTOMY, AN UNKNOWN ERROR OCCURRED AND BECAME NOT TO ACTIVATE. GEN11 WAS USED. 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 14461604 ↗
• MalfunctionMay 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN OPEN BIOLOGICAL VALVE (MAGNA MITRAL EASE) REMOVAL PROCEDURE A SNGCB WAS USED, BUT THE BLADE BROKE WHEN THE NURSE WIPED THE TIP OF THE BLADE. THERE IS A POSSIBILITY THAT THE DEVICE TOUCHED THE METAL OR THE PLASTIC AROUND THE BIOLOGICAL VALVE. THE SNGCB HAD SEVERAL SCRATCHES ON THE TIP AND SLIGHT DEFORMED. NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. 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 14286647 ↗
• MalfunctionMar 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE NOT WORKING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966739 ↗
• MalfunctionMar 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE BROKE. NO PIECES 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 13825264 ↗
• MalfunctionMar 3, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE LIMB AMPUTATION OF A DOG. THAT THE TIP OF THE BLADE BROKE OFF ON THE DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663729 ↗
• MalfunctionFeb 4, 2022Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING A CONIZATION, ¿RELAX PRESSURE ON BLADE¿ WAS DISPLAYED AFTER THE DEVICE WAS USED FOR 5 MINUTES. THEN THE BLADE BROKE WHEN CLEANING THE BLADE. NO PIECES 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 13453778 ↗
• MalfunctionFeb 3, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE CAME OFF WHEN THE DEVICE WAS CONNECTED TO THE HANDPIECE. NO PIECES 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 13443628 ↗
• MalfunctionJan 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP WAS BROKEN AS THE SURGEON TRIED TO LOCK THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282134 ↗
• MalfunctionJan 4, 2022Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING A SEMI-OPEN OTORHINOLARYNGOLOGY, AN UNKNOWN ERROR OCCURRED AND BECAME NOT TO FUNCTION. GEN11 WAS USED. THE NUMBER OF REMAINING USES OF HPBLUE WAS 55. THE DEVICE WAS USED ON THE BLOOD VESSELS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE BLADE BROKE WHEN THE SALES REP TOUCHED THE DEVICE, AFTER RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157645 ↗
• MalfunctionDec 14, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY, AN UNKNOWN ERROR OCCURRED. THE HANDPIECE WAS RECONNECTED, AND THE DEVICE WAS RESTARTED, BUT THE ISSUE DID NOT IMPROVE. 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 12994345 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A ENT PROCEDURE, TECH WAS TIGHTENING THE BLADE ON THE HARMONIC SYNERGY DEVICE. AS TORQUE WRENCH WAS SLID OFF THE BLADE BROKE DUE TO PULLING THE WRENCH OFF AT A BAD ANGLE. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING. THE EVENT DID NOT OCCUR DURING FIELD INSPECTION. THE EVENT DID NOT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. PATIENT WAS NOT AFFECTED. DEVICE WAS REPLACED PRIOR TO CASE STARTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919761 ↗