Harmonic Synergy SNGHKRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705036002819), received between Dec 6, 2017 and Jun 26, 2026 — classified as 7 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Material Separation” (24 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 61 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• 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 18595853 ↗
• 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 18595844 ↗
• 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 18595835 ↗
• MalfunctionOct 30, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A THYROIDECTOMY THE SYNERGY HOOK NOT WORKING IN 1ST CASE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031490 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  TITLE: ANALYSIS OF DIFFERENT TECHNIQUES OF TONSILLECTOMY: AN INSIGHT. AUTHORS: AJAZ UL HAQ, CHETAN BANSAL, APOORVA KUMAR PANDEY, V. P. SINGH. CITATION: INDIAN J OTOLARYNGOL HEAD NECK SURG (DECEMBER 2022); 74(SUPPL 3):S5717¿S5730. HTTPS://DOI.ORG/10.1007/S12070-021-02948-4. THE OBJECTIVE OF THIS STUDY IS TO COMPARE THREE DIFFERENT SURGICAL TECHNIQUES OF TONSILLECTOMY NAMELY THE COLD DISSECTION SNARE TECHNIQUE (CDST), BIPOLAR ELECTRO-DISSECTION TECHNIQUE (BEDT) AND HARMONIC SCALPEL TECHNIQUE (HST) AND TO IDENTIFY THE METHOD WHICH IS SAFE, WITH LESS OPERATIVE TIME, WHICH OFFERS DECREASED INTRA-OPERATIVE BLOOD LOSS AND WITH LOWEST POST-OPERATIVE MORBIDITY AND COMPLICATIONS. THIS PROSPECTIVE AND COMPARATIVE STUDY WAS CONDUCTED OVER A TIME DURATION OF 1 YEAR 6 MONTHS FROM JANUARY 2018 TO JULY 2019 AFTER THE APPROVAL FROM ETHICAL COMMITTEE. IT ENROLLED 150 PATIENTS OF AGE 4 TO 40 YEARS WITH RECURRENT TONSILLITIS. IN THIS STUDY 62% WERE MALE AND 38% WERE FEMALE. 56.67% BELONG TO URBAN DWELLING AREA WHEREAS 43.33% WERE FROM RURAL AREA. IN COLD DISSECTION SNARE TECHNIQUE (CDST), TONSILLECTOMY WAS DONE BY PALATOGLOSSAL INCISION USING TOOTHED WAUGH FORCEPS. IN BIPOLAR ELECTRO-DISSECTION TECHNI

  Patient problems: Dehydration; Dysphagia/ Odynophagia; Hemorrhage/Blood Loss/Bleeding; Pain; Speech Disorder; Unspecified Infection; Vomiting

  MAUDE report 17327169 ↗
• MalfunctionJun 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE IN CARDIOVASCULAR SURGERY, THE BLADE BROKE. 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 17171172 ↗
• MalfunctionMar 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE IN CARDIOVASCULAR SURGERY, THE BLADE TIP WAS BROKEN DURING USE. 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 16506236 ↗
• MalfunctionFeb 15, 2023Failure to Read Input Signal; Material Integrity Problem; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT, DURING CONIZATION, ¿RELAX PRESSURE ON BLADE¿ WAS DISPLAYED AND THE DEVICE BECAME NOT TO FUNCTION DURING USE. IT WAS FOUND THAT THERE IS A RACK ON THE BLADE. THE NUMBER OF REMAINING USE OF HPBLUE WAS 79. 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 16380129 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A CABG, THE DEVICE FUNCTIONED ON ITS OWN WHEN IT WAS IN THE DRAPE POCKET ON THE RIGHT SIDE OF THE PATIENT. IT WAS ALREADY CONNECTED WITH THE HANDPIECE AND THE FUNCTIONAL TEST WAS NOT PERFORMED YET. THE ACTIVATION SOUND WAS NOT HEARD. THE FOOT SWITCH HAS BEEN PLACED. THE BLADE OF THE DEVICE TOUCHED THE SURGEON, AND HE NOTICED BECAUSE OF THE PAIN, AND HE GOT A BLISTER. AFTER THE ISSUE OCCURRED, GEN11 SCREEN REMAINS UNTESTED. ANOTHER DEVICE AND HANDPIECE WERE USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 16158635 ↗
• MalfunctionJan 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, BLADE WAS BROKEN WHEN TURNING TORQUE WRENCH. 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 16094636 ↗
• MalfunctionDec 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING CORONARY ARTERY BYPASS GRAFTING, THE BLADE TIP WAS BROKEN DURING USE. 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 16042668 ↗
• MalfunctionDec 6, 2022Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN OB-GYN PROCEDURE, ¿REPLACE INSTRUMENT¿/¿BLADE ERROR DETECTED¿ WERE DISPLAYED FREQUENTLY DURING CONIZATION. THE DEVICE TOUCHED FORCEPS SEVERAL TIMES. AND THE TIP OF BLADE FELL OFF WHEN THE CORD WAS PLUGGED. 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 15924079 ↗
• MalfunctionNov 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING, THE DEVICE SUDDENLY BECAME NOT TO BE ACTIVATED, AND THE BLADE WAS BROKEN. THE DEVICE WAS USED ON BLOOD VESSELS. 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 15776320 ↗
• MalfunctionAug 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A CARDIOVASCULAR SURGERY PROCEDURE, THE BLADE WAS BROKEN. 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 15249294 ↗
• MalfunctionAug 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HOOK OF HANDLE BROKEN OFF AFTER 15 MINUTES OF VESSEL PREPARATION. CONTACT ONLY WITH TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15221433 ↗
• MalfunctionAug 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING THE BLADE WAS BROKEN. THE DEVICE WAS SHARPENED BEFORE USE. 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 15209987 ↗
• MalfunctionMay 13, 2022Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, AN UNKNOWN ERROR OCCURRED. 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 14402600 ↗