Harmonic Ace ACE23ERecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705036000891), received between Dec 4, 2017 and Jun 12, 2023 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WHITE TISSUE PAD WAS UP. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105393 ↗
• MalfunctionJun 9, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WHITE TISSUE PAD WAS UP. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098762 ↗
• MalfunctionAug 30, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿DEVICE ERROR¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. AND THEN THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384501 ↗
• MalfunctionJul 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198804 ↗
• MalfunctionMar 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568215 ↗
• MalfunctionDec 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TITANIUM TIP WAS FOUND BROKEN DURING PROCEDURE OF LIGATION OF COMMUNICATING BRANCH. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS. AND ALL THE PARTS WERE INTACT WHEN THEY WERE PUT TOGETHER. THE BROKEN PIECE WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10932574 ↗
• MalfunctionJul 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT TITANIUM TIP WAS BROKEN DURING PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302008 ↗
• MalfunctionApr 28, 2020Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A "REPLACE INSTRUMENT" ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007511 ↗
• MalfunctionApr 27, 2020Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A "REPLACE INSTRUMENT" ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003543 ↗
• MalfunctionJan 15, 2020Device Fell

  IT WAS REPORTED THAT THE WHITE TISSUE PAD FELL OFF DURING THE PROCEDURE. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594120 ↗
• InjuryDec 24, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: DOES ULTRASONIC ENERGY FOR SURGICAL DISSECTION REDUCE THE INCIDENCE OF RENAL TRANSPLANT LYMPHOCELE? AUTHOR/S: E.W. NELSON, M.E. GROSS, M.C. MONE, H.J. HANSEN, X. SHENG, K.M. CANNON, AND S. ALDER. CITATION: TRANSPLANTATION PROCEEDINGS, 43, 3755¿3759 (2011), DOI:10.1016/J.TRANSPROCEED.2011.08.079. THIS RETROSPECTIVE COHORT STUDY AIMED TO COMPARE THE RATE OF POSTTRANSPLANT LYMPHOCELE DEVELOPMENT USING ULTRASONIC DISSECTION (UD) VERSUS A HISTORIC REVIEW OF LYMPHATIC CONTROL USING SUTURE LIGATION. FROM JANUARY 1994 TO DECEMBER 2009, RECORDS OF A TOTAL OF 532 PATIENTS WHO RECEIVED TRANSPLANTS WERE REVIEWED. WITHIN THIS POPULATION, 259 CASES HAD SUTURE LIGATION AND 273 CASES (N= 58.2% MALES, MEAN AGE: 39.9 YEARS) EMPLOYED THE USE OF UD. THE UD EQUIPMENT USED IN THIS STUDY WAS THE HARMONIC ACE SHEARS WITH A LENGTH OF 23 CM (ETHICON) TO CONTROL LYMPHATIC VESSELS. COMPLAINTS INCLUDED LYMPHOCELE (N=9.2%). TREATMENT COULD BE EITHER ASPIRATION ALONE, INITIAL PERCUTANEOUS DRAINAGE WITH EVENTUAL SURGICAL DRAINAGE, OR SURGICAL DRAINAGE WITHOUT ATTEMPTED PRIOR TREATMENT WITH PERCUTANEOUS ASPIRATION. THERE WAS NO STATISTICALLY ADVANTAGE TO THE USE OF UD FOR

  Patient problems: No Code Available; Swollen Lymph Nodes

  MAUDE report 9516453 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem

  TITLE: ULTRASONICALLY ACTIVATED SHEARS REDUCE BLOOD LOSS WITHOUT INCREASING INFLAMMATORY REACTIONS IN OPEN DISTAL GASTRECTOMY FOR CANCER: A RANDOMIZED CONTROLLED STUDY. AUTHOR/S: SEUNG-YOUNG OH, MD, BORAM CHOI, MS, KYUNG-GOO LEE, MD, HWI-NYEONG CHOE, BN, HYE-JOO LEE, BN, YUN-SUHK SUH, MD, SEONG-HO KONG, MD, PHD, HYUK-JOON LEE, MD, PHD, WOO HO KIM, MD, PHD AND HAN-KWANG YANG, MD, PHD. CITATION: ANN SURG ONCOL (2017) 24:494¿501; DOI 10.1245/S10434-016-5518-3. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF ULTRASONICALLY ACTIVATED SHEARS (UAS) THROUGH A COMPARISON WITH CONVENTIONAL MONOPOLAR ELECTROCAUTERY (CME) IN OPEN RADICAL DISTAL GASTRECTOMY (DG) FOR GASTRIC CANCER. FROM OCTOBER 2011 TO NOVEMBER 2012, A TOTAL OF 49 PATIENTS WERE ENROLLED AND RANDOMLY ASSIGNED TO THE CME (N=24) AND UAS GROUPS (N=25: N=18 MALES AND N=7 FEMALES, MEAN AGE: 54.7 YEARS, AGE RANGE: 34-70 YEARS, MEAN BMI: 23.4 KG/M2, BMI RANGE: 19.5-29.5). 23-CM HARMONIC ACE CURVED SHEARS (ETHICON) WAS USED IN THE UAS GROUP FOR ROUTINE PROCEDURES IN DG EXCEPT FOR MAJOR VESSEL LIGATION. COMPLAINTS INCLUDED FLUID COLLECTION (N=1) AND PANCREATIC FISTULA (N=1). THE RESULTS OF THIS STUDY SHOW

  Patient problems: Fistula; Swelling

  MAUDE report 9505639 ↗
• MalfunctionNov 8, 2019Device Fell

  IT WAS REPORTED THAT THE WHITE TISSUE PAD WAS FALLEN OFF DURING PROCEDURE. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298040 ↗
• MalfunctionNov 8, 2019Device Fell

  IT WAS REPORTED THAT THE WHITE TISSUE PAD WAS FALLEN OFF DURING PROCEDURE. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9296398 ↗
• MalfunctionSep 10, 2019Break

  IT WAS REPORTED THAT TITANIUM TIP WAS BROKEN DURING PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8980893 ↗
• MalfunctionApr 2, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474086 ↗
• MalfunctionFeb 13, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ¿TIGHTEN ASSEMBLY¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336362 ↗
• MalfunctionJan 11, 2019Break

  IT WAS REPORTED THAT THE TITANIUM TIP WAS BROKE DURING THE PROCEDURE. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO REPORT ON THE PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242371 ↗
• MalfunctionJan 11, 2019Break

  IT WAS REPORTED THAT TITANIUM TIP WAS BROKEN DURING PROCEDURE. THE BROKEN PIECE WAS NOT FOUND. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239993 ↗
• MalfunctionJan 10, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED THAT THE TISSUE PAD FELL OFF. AND IT TOOK MORE THAN 10 MINUTES TO FIND THE BROKEN PIECE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8233822 ↗
• MalfunctionJan 10, 2019Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRIC CYST PROCEDURE, IT WAS REPORTED THAT THE TITANIUM TIP BROKE DURING SURGERY. IT TOOK MORE THAN 1 HOUR TO FIND THE BROKEN PIECE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8233781 ↗
• MalfunctionDec 5, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136114 ↗
• MalfunctionNov 8, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8053393 ↗
• MalfunctionOct 10, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WHITE TISSUE PAD WAS FALLEN OFF DURING THE PROCEDURE. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953308 ↗
• MalfunctionOct 10, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953268 ↗