ACS CDSH45DRecalls & reported problems
American Contract Systems, Inc. · CMC SHOULDER ARTHROSCOPY · Class 2
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 00191072046291), received between Mar 3, 2020 and Mar 3, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination 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
- Contamination /Decontamination Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2020Contamination /Decontamination Problem
WE FOUND A BUG IN THE PACK (ON LID OF IRRIGATION TUB) BEFORE THE PATIENT WAS IN THE ROOM, ALL SET UP WAS TAKEN DOWN AND RESET. THE PACK WAS CMC SHOULDER ARTHROSCOPY PACK AND THE REF# (B)(4). I HAVE THE LID WITH THE BUG IN MY OFFICE FOR PICK UP.
Patient problems: No Patient Involvement
MAUDE report 9779407 ↗
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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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