AESCULAP FB850RRecalls & reported problems
Aesculap AG · COOLEY Rib Spreader, complete set, 7", (180 mm), for adults, blades 32 x 50 mm, width: 290 mm, opening width: 190 mm, non-sterile, reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653158218), received between Dec 1, 2020 and Dec 17, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (2 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
Device problems
- Mechanical Jam2
- Separation Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2020Separation Problem; Separation Problem
THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11030798 ↗InjuryDec 1, 2020Mechanical Jam; Mechanical Jam
InjuryDec 1, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FB850R - COOLEY STERNOTOMY SPREADERADULT32X50MM. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING AN OPEN HEART SURGERY ON (B)(6) 2020 THE COOLEY STERNOTOMY SPREADERADULT32X50MM (A BRAND NEW DEVICE) WAS USED AND GOT STUCK IN A PATIENT'S CHEST. THE DEVICE HAD TO BE FORCIBLY REMOVED FROM THE CHEST DURING THE PROCEDURE. THE INCIDENT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR TO A PATIENT DEATH. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Insufficient Information
MAUDE report 10930666 ↗
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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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