Ace + 7 HARH45RRecalls & reported problems
Sterilmed, Inc. · HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551045278), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY WITH A REPROCESSED HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS AND THE JAW BROKE OFF AND FELL INTO PATIENT. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK AND NO SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE BREAK. THE TIP WAS RETRIEVED. THERE WAS PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13005801 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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