CUSA® Excel C6636Recalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel 36 kHz CEM™ Nosecone · Class U
All models of CUSA Excel (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780026136), received between Mar 23, 2023 and Jul 8, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Remains Activated” (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.
Reports received per month
Most reported problems
Device problems
- Device Remains Activated1
- Failure to Advance1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024Device Remains Activated; Device Remains Activated
A FACILITY REPORTED THAT THE CUSA EXCEL 36KHZ CEM NOSECONE (C6636) GENERATED POWER EVEN THOUGH THE HAND SWITCH WAS NOT PRESSED, AND IT OCCURRED CONTINUOUSLY DURING SURGERY. ANOTHER NOSECONE WAS USED AND IT WORKED PROPERLY. NO INJURY WAS REPORTED, BUT A POSSIBILITY OF BURN INJURY WAS REPORTED. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19697434 ↗InjuryMay 31, 2024Failure to Advance; Failure to Advance
MalfunctionMar 23, 2023Melted; Melted
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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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