CUSA® Excel C4614SRecalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel 36kHz 1.98mm Curved Extended Standard Tip · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780026051), received between Jun 11, 2025 and Aug 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Output below Specifications” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Output below Specifications3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Output below Specifications; Output below Specifications
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2025-00095: A FACILITY REPORTED THAT DURING AN "S6 SEGMENTECTOMY", AN AMPLITUDE ERROR OCCURRED WHEN USING THIS LOANER CUSA EXCEL 36KHZ CURVED EXTENDED STANDARD TIP (C4614S). BY USING A TIP FROM DIFFERENT LOT, IT WORKED PROPERLY. THERE WERE MORE THAN 30 MINUTES OF SURGICAL DELAY, BUT NO ADVERSE CONSEQUENCES TO THE PATIENT OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742323 ↗MalfunctionAug 7, 2025Output below Specifications; Output below Specifications
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2025-00096: A FACILITY REPORTED THAT DURING AN "S6 SEGMENTECTOMY", THE PHYSICIAN STOPPED USING THE CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP (C4614S) DUE TO AN OUTPUT ERROR DURING TEST. THERE WAS MORE THAN 30 MINUTES SURGICAL DELAY, BUT NO ADVERSE CONSEQUENCES TO THE PATIENT OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742007 ↗MalfunctionJun 11, 2025Output below Specifications; Output below Specifications
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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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