ACE+ HAR36RRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888551045117), received between Jan 31, 2019 and Jul 20, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TIP BROKE OFF. THE TIP WAS BELIEVED TO RETRIEVED AND DISCARDED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM. ATTEMPT HAS BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070196 ↗
• MalfunctionMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE USING A REPROCESSED HARMONIC SCALPELS/SHEARS THE DEVICE BLADE BROKE OFF. FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655507 ↗
• MalfunctionFeb 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE DISTAL TIP DETACHED FROM THE DEVICE. THE DETACHED PIECE WAS RECOVERED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453764 ↗
• MalfunctionJan 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS, THE BLADE BROKE OFF AND WAS RETRIEVED. IT IS UNKNOWN AS TO HOW THE BLADE WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13334024 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TIP OF DEVICE WAS BROKEN. IT IS UNKNOWN IF IT COMPLETELY DETACHED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962544 ↗
• MalfunctionDec 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE DEVICE WAS NOT COAGULATING CORRECTLY. THE SURGEON FELT LIKE THE DEVICE WAS NOT PERFORMING AS INTENDED REGARDING HEMOSTASIS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE OBSERVED ON THE DEVICE. SURGERY WAS NOT DELAYED DUE TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962362 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE BLADE TIP BROKE. IT WAS DESCRIBED TO HAVE LOOKED LIKE THE ENTIRE TIP OF THE JAW WAS THERE BUT THAT THE HINGE MAY HAVE BROKEN, BUT ALL CONTENTS WERE THERE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962192 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND DURING COLPOTOMY CREATION WHEN THE BLADE CAME IN CONTACT WITH THE UTERINE MANIPULATOR THE ACTIVE BLADE BROKE. BROKEN PIECE WAS RECOVERED WITHOUT ADDITIONAL ASSISTANCE. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK. ANOTHER REPROCESSED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THIS EVENT HAS BEEN ASSESSED AS NOT MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523518 ↗
• MalfunctionSep 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TISSUE PAD BROKE OFF INSIDE OF THE PATIENT. THE PAD WAS FOUND AND REMOVED FROM THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489130 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TISSUE PAD FELL OFF INTO PATIENT. IT APPEARED ALMOST LIKE IT MELTED. THE TISSUE PAD WAS RETRIEVED FROM THE PATIENT WITHOUT ANY ADVERSE OUTCOMES. ONCE THE FRAGMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK, NOR A SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316809 ↗
• MalfunctionMar 11, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC SLEEVE PROCEDURE WITH REPROCESSED HARMONIC SCALPELS/SHEARS AND THE DEVICE WAS NOT PROVIDING ADEQUATE HEMOSTASIS. DURING THE PROCEDURE THE DEVICE WAS CUTTING BUT NOT COAGULATING. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THERE WAS NO DELAY DUE TO THE ISSUE. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11467762 ↗
• MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SALPINGO-OOPHORECTOMY WITH REPROCESSED HARMONIC SCALPELS/SHEARS, AND THE TIP BROKE OFF WHILE REMOVING THE OVARIAN TUBES. THE DEVICE WAS USED ON SOFT TISSUE AND VESSELS; IT WAS NOT USED FOR OCCLUSION. THERE WAS NO DELAY TO SURGERY; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10686757 ↗
• MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY WITH REPROCESSED HARMONIC SCALPELS/SHEARS AND THE HARMONIC TEFLON PAD FELL OFF INTO PATIENT DURING THE PROCEDURE. THE PAD WAS CAREFULLY REMOVED BY THE PHYSICIAN. NO FURTHER INTERVENTION WAS NECESSARY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10686671 ↗
• MalfunctionMar 13, 2020Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND A PLASTIC PIECE ON THE BLADE MELTED OFF THE DEVICE AND THEN ADHERED TO THE OVARY. SURGEON WAS ABLE TO REMOVE THE PIECE SUCCESSFULLY. THE DEVICE PASSED PRE-TEST AND WAS WORKING NORMALLY PRIOR TO THE ISSUE. THE GENERATOR DID NOT SHOW ANY ERROR MESSAGES. THE DEVICE WAS CHANGED TO AN ALTERNATIVE DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. IT WAS NOTED THAT THE INTENT OF THE PROCEDURE WAS ALTERED, HOWEVER EXACT DETAILS ON HOW IT WAS ALTERED HAS NOT YET BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829772 ↗
• MalfunctionAug 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH A REPROCESSED HARMONIC ACE® 5 MM DIAMETER SHEARS + ADAPTIVE TISSUE TECHNOLOGY 5MM X 36CM AND THE TISSUE PAD WAS DISLODGED AND RETRIEVED EASILY FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. GEN11 GENERATOR WITH LATEST SOFTWARE VERSION WAS USED DURING THE PROCEDURE. THERE WAS NO DELAY TO SURGERY. ANOTHER DEVICE WAS OPENED TO COMPLETE CASE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8918989 ↗
• MalfunctionMay 8, 2019Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR WITH HARMONIC SCALPELS/SHEARS. THE GREATER CURVATURE OF THE STOMACH WAS MOBILIZED USING THE HARMONIC SCALPEL INCLUDING ALL POSTERIOR GASTRIC ATTACHMENTS BEGINNING AT THE HILUM OF THE SPLEEN EXTENDING TO THE LEFT CRUS OF THE DIAPHRAGM. THE WHITE PAD TIP OF THE HARMONIC SCALPEL HAND PIECE STARTED TO MELT AND SLIDE OFF. IT WAS REMOVED FROM THE STERILE FIELD AND REPLACED. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592525 ↗
• MalfunctionJan 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH HARMONIC SCALPELS/SHEARS, AND IN THE MIDDLE OF THE PROCEDURE THE BLADE BROKE OFF THE DEVICE. THE SURGEON RETRIEVED THE BROKEN PIECE AND USED A NEW DEVICE TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT. THE DEVICE HAD PATIENT CONTACT, HOWEVER THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294201 ↗