A&E Medical / Rotating Surgical Punches 080-403Recalls & reported problems
A & E Medical Corporation · Rotating Surgical Punches, 1 per pouch · Class 1
All models of A&E Medical / Rotating Surgical Punches (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10841291105183), received between Jan 20, 2021 and Dec 5, 2024 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem3
- Mechanical Problem2
- Physical Resistance/Sticking2
- Device Contaminated During Manufacture or Shipping1
- Difficult or Delayed Separation1
- Dull, Blunt1
- Failure to Cut1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Great Vessel Perforation1
- Laceration(s)1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20853102 ↗MalfunctionOct 28, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545486 ↗MalfunctionOct 1, 2024Dull, Blunt; Dull, Blunt
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344930 ↗MalfunctionJun 14, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538955 ↗MalfunctionJan 29, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18595244 ↗MalfunctionMar 27, 2023Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619897 ↗InjurySep 20, 2022Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation
IT WAS REPORTED THE PUNCH LOCKED AND WOULD NOT RELEASE CAUSING SMALL PART OF AORTA TO TEAR WHICH WAS FIXED WITH SUTURE. THIS CAUSED A DELAY IN THE SURGERY.
Patient problems: Great Vessel Perforation
MAUDE report 15459333 ↗MalfunctionSep 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15437218 ↗MalfunctionNov 16, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH WAS ENGAGED IN THE PATIENT'S AORTA AND IT DID NOT SPRING BACK OPEN WHEN HE RELEASED HIS THUMB. DR. (B)(6) USED ONE HAND TO STABILIZE THE AORTA AND ONE HAND TO PULL THE PUNCH OPEN AND IT RIPPED OUT OF THE AORTA TEARING A PIECE OFF AND THE PUNCH WAS STILL CLOSED. IT NEVER RELEASED. THE AORTA HAD TO BE REPAIRED WITH SEVERAL SUTURES.
Patient problems: Laceration(s)
MAUDE report 12824001 ↗MalfunctionJan 20, 2021Mechanical Jam; Mechanical Jam
AORTIC PUNCH TIP FAILED TO RETRACT REQUIRING MANUAL REMOVAL WITH SURGICAL BLADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11201752 ↗
Other Punch, Surgical devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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