A&E Medical / Rotating Surgical Punches 080-401Recalls & 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
Quick summary
This A&E Medical rotating surgical punch is a hand tool for cutting round openings in tissue. Reports mostly describe sterile packaging problems, including foreign objects found inside the sealed pouch, plus contamination concerns and blades that stay dull or fail to cut cleanly, sometimes fraying the tissue. There are 29 reports, no deaths and 2 injuries. No recalls name this device, and reports in the past 12 months (2) are far fewer than the 15 in the prior year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10841291105169), received between May 8, 2020 and Dec 8, 2025 — classified as 2 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (10 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 Problem10
- Contamination /Decontamination Problem7
- Mechanical Problem5
- Dull, Blunt4
- Failure to Cut3
- Defective Device2
- Device Contaminated During Manufacture or Shipping2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Unspecified Tissue Injury3
- Excessive Tear Production1
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON USED THE DEVICE TO PREPARE THE PROXIMAL OPENING IN THE AORTA FOR THE GRAFT. HOWEVER, THE PUNCH FAILED TO MAKE A SUFFICIENT HOLE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752631 ↗MalfunctionNov 26, 2025Device 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 23656576 ↗MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PUNCH DOES NOT CREATE A CIRCULAR HOLE. AS IT IS RETRACTED, IT TENDS TO FLAKE/FRAY THE AORTA. HOSPITAL REPORTED THAT THERE WAS NO DAMAGE TO THE PATIENT OR OTHER USER. THERE WAS NO SURGICAL DELAY FOUND. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22286614 ↗MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Tissue Injury
MAUDE report 22286613 ↗MalfunctionJun 6, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PUNCH DOES NOT CREATE A CIRCULAR HOLE. AS IT IS RETRACTED, IT TENDS TO FLAKE/FRAY THE AORTA. HOSPITAL REPORTED THAT THERE WAS NO DAMAGE TO THE PATIENT OR OTHER USER. THERE WAS NO SURGICAL DELAY FOUND. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22158921 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143727 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143722 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143715 ↗MalfunctionJun 4, 2025Contamination /Decontamination Problem; Packaging Problem; Contamination /Decontamination Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143711 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143710 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143703 ↗MalfunctionApr 10, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A SMALL BLACK SHAVING (DEBRIS) FELL OUT OF THE AORTIC PUNCH WHILE TESTING THE PLUNGER MECHANISM PRIOR TO SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21816437 ↗MalfunctionApr 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772847 ↗MalfunctionApr 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772842 ↗MalfunctionApr 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772835 ↗MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635521 ↗MalfunctionFeb 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313487 ↗MalfunctionJun 12, 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 19519533 ↗MalfunctionJun 12, 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 19519522 ↗MalfunctionApr 29, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING A PROCEDURE WHILE OPENING THE PACKAGE ON THE BACK TABLE, THE SURGICAL TEAM IDENTIFIED A SMALL, CLEAR PIECE OF PLASTIC CLINGING ON THE AORTIC PUNCH. THE CLEAR PIECE AND INSTRUMENT WERE REMOVED FROM THE SURGICAL FIELD. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203802 ↗MalfunctionDec 18, 2023Packaging 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 18345560 ↗MalfunctionDec 12, 2023Dull, Blunt; Physical Resistance/Sticking; Dull, Blunt; Physical Resistance/Sticking
IT IS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE, THE INSTRUMENT LOCKED AND DID NOT CUT. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18309024 ↗MalfunctionNov 14, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE SURGEON REMOVED THE CAP AND PRESSED THE PUNCH PRIOR TO PUTTING THE INSTRUMENT INTO THE SURGICAL SITE. THE SMALL PIECE OF MATERIAL CAME OUT BEFORE THE PUNCH WAS USED WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18131633 ↗MalfunctionNov 14, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A ROTATING SURGICAL PUNCH WAS USED BY THE SURGEON TO MAKE A HOLE FOR PROXIMAL ANASTOMOSIS DURING A CORONARY ARTERY BYPASS PROCEDURE. AFTER USE OF THE PUNCH, THE SURGEON DISCOVERED A SMALL PIECE OF PLASTIC SITTING ON TOP OF THE AORTA. THE SMALL PIECE OF PLASTIC DISLODGED FROM THE PUNCH AND WAS NOTICED BY THE SURGEON BEFORE IT FELL INTO THE HOLE MADE IN THE AORTA BY THE PUNCH. THE SURGEON GAVE THE SMALL PIECE OF PLASTIC TO THE SCRUB NURSE TO KEEP ON THE BACK TABLE AND QUARANTINE. THERE WAS NO APPARENT HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18131200 ↗MalfunctionJul 24, 2023Dull, 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 17379732 ↗
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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