Ace + 7 HARH36RRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888551045247), received between Jul 15, 2021 and Feb 1, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE WITH A HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND A DETACHMENT IN THE PATIENT ISSUE OCCURRED. DURING THE PROCEDURE, THE WHITE INSULATED PIECE CAME OFF AND THE ULTRASONIC JAW PIECE WAS GLOWING. THERE WAS NO PATIENT HARM, BUT THE PIECE THAT BROKE OFF HAD TO BE RETRIEVED USING ANOTHER LAPAROSCOPIC INSTRUMENT. THE REUSABLE CORD WAS SENT TO STERILE PROCESSING FOR TESTING AND IT WAS WORKING CORRECTLY. NO PATIENT INJURY OR CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED. THE TIP WAS GLOWING HOT AND THE WHITE PIECE CAME OFF. NO SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE FAILURE. THE ULTRASONIC JAW PIECE WAS GLOWING ORANGE HOT. THE DETACHMENT IN THE PATIENT WAS ASSESSED AS MDR REPORTABLE. THE TIP GLOWING ISSUE WAS ASSESSED AS NOT MDR REPORTABLE FOR A DAMAGED-JAW ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281434 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE WITH A HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND A BLADE BREAK IN PATIENT ISSUE OCCURRED. DURING THE CULPOTOMY, THE DEVICE HIT THE UTERINE MANIPULATOR AT WHICH TIME THE BLADE BENT. UPON REMOVAL FROM THE PATIENT, THE BLADE BROKE OFF COMPLETELY. BROKEN PIECE OF THE BLADE WAS RECOVERED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WITH THE BROKEN BLADE TAPED TO THE PACKAGE WILL BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED. THE BLADE WAS NOT STUCK IN THE PATIENT. DID NOT REQUIRE ANOTHER DEVICE TO REMOVE NOR DID IT REQUIRE SURGICAL INTERVENTION. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK. THERE WAS NO SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE BREAK. THE ISSUE WAS ASSESSED AS MDR REPORTABLE FOR A BLADE BREAK IN PATIENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744335 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS. THE DEVICE WAS USED OFF LABEL ON A METAL UTERINE MANIPULATOR AND THE BLADE FRACTURED AND WAS UNUSABLE. THERE WAS NO DIFFICULTY NOTICED PRIOR TO THE BREAK. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311639 ↗
• MalfunctionJan 27, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND WHILE USING THE DEVICE A BLUE PIECE OF PLASTIC FELL OFF. THE BLUE PLASTIC PIECE WAS RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367322 ↗
• MalfunctionDec 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE BLADE OF THE DEVICE BROKE OFF DURING THE PROCEDURE. THE BLADE WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976889 ↗
• MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE BLADE BROKE OFF AND FELL IN THE PATIENT. THE BLADE WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS EVENT HAS BEEN ASSESSED AS AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228123 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND A PIECE OF THE JAW BROKE OFF INSIDE THE PATIENT. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK OR ANY SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE BREAK. THE FRAGMENT WAS REMOVED EASILY WITH A 5MM DEBAKEY GRASPER. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228099 ↗
• MalfunctionJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE TISSUE PAD FELL OFF WHILE IN USE. TISSUE PAD WAS RECOVERED. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175982 ↗