Harmonic Synergy SNGHK2Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705036013815), received between Nov 27, 2019 and Oct 11, 2021 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE THERE WAS AN INSTRUMENT ERROR. NO MORE DETAILED INFO. THERE WERE NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605520 ↗
• MalfunctionSep 15, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPON RECEIPT OF THE DEVICE, THEY OPENED THE BOX AND THE DEVICES APPEARED TO HAVE "CRACKS" IN THE INDIVIDUAL PACKAGING THAT WAS ALLOWING LIGHT TO GET THROUGH. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10534658 ↗
• MalfunctionSep 15, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPON RECEIPT OF THE DEVICE, THEY OPENED THE BOX AND THE DEVICES APPEARED TO HAVE "CRACKS" IN THE INDIVIDUAL PACKAGING THAT WAS ALLOWING LIGHT TO GET THROUGH. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10534632 ↗
• MalfunctionSep 15, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPON RECEIPT OF THE DEVICE, THEY OPENED THE BOX AND THE DEVICES APPEARED TO HAVE "CRACKS" IN THE INDIVIDUAL PACKAGING THAT WAS ALLOWING LIGHT TO GET THROUGH. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10534448 ↗
• MalfunctionSep 15, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPON RECEIPT OF THE DEVICE, THEY OPENED THE BOX AND THE DEVICES APPEARED TO HAVE "CRACKS" IN THE INDIVIDUAL PACKAGING THAT WAS ALLOWING LIGHT TO GET THROUGH. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10534432 ↗
• MalfunctionMar 3, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BLADE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781091 ↗
• MalfunctionMar 3, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BLADE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781014 ↗
• MalfunctionMar 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BLADE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780983 ↗
• MalfunctionMar 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BLADE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780773 ↗
• MalfunctionMar 3, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BLADE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780615 ↗
• MalfunctionMar 3, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BLADE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780603 ↗
• MalfunctionFeb 11, 2020Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT, THE TIP OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT. IT WAS NOTED THAT "IT MIGHT HAVE CAME IN CONTACT WITH A METAL PICK UP DEVICE." THE BROKEN PIECE WAS FOUND AND REMOVED FORM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695839 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem

  TITLE: QUICKER YET SAFE: SKELETONIZATION OF 1640 INTERNAL MAMMARY ARTERIES WITH HARMONIC TECHNOLOGY IN 965 PATIENTS. AUTHOR: TERESA M. KIESER, M. SARAH ROSE, UTHMAN ALUTHMAN AND KISHAN NARINE. CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 45 (2014) E142¿E150 / DOI:10.1093/EJCTS/EZU024. THE PURPOSE OF THIS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY COLLECTED DATA WAS TO COMPARE MAJOR ADVERSE CARDIAC EVENTS (MACES) RELATED TO IMA GRAFTING BETWEEN NON-HARMONIC SCALPEL (HS) AND HS PATIENTS, AND COMPARE TIMES OF HARVEST BETWEEN NON-HS HARVEST AND HS HARVEST. FROM JULY 2003 TO JULY 2013, A TOTAL OF 1051 PATIENTS WITH ISOLATED CORONARY ARTERY BYPASS GRAFT (CABG) WERE INCLUDED IN THE STUDY. IMA CONDUITS WERE HARVESTED IN A SKELETONIZED MANNER EITHER WITH THE TRADITIONAL SKELETONIZATION TECHNIQUE (WITH USE OF THE CAUTERY TIP WITHOUT POWER AS A DISSECTOR) (N=86, N=22 FEMALE, MEAN AGE 67.7 YEARS) OR WITH AN ULTRASONIC SCALPEL (HARMONIC SCALPEL; ETHICON ENDO-SURGERY) (N=965, N=206 FEMALE, MEAN AGE 64.7 YEARS). IN HARMONIC SCALPEL GROUP, THE HARMONIC SCALPEL WAS USED TO ISOLATE AND FREE THE IMA, FROM ITS DISTAL BIFURCATION INTO THE SUPERIOR EPIGASTRIC AND MUSCULOPHRENIC BRANCHES TO PROXIMA

  Patient problems: Unspecified Infection

  MAUDE report 9386033 ↗