CUSA® Excel C4604ELTRecalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel CUSA® Excel 23KHz 1.98mm Extended Life Laparoscopic 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780025931), received between Feb 8, 2023 and Oct 2, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
InjuryMay 14, 2025Overheating of Device; Overheating of Device
MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED THAT DURING USE OF THE CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT (C4604ELT), THE ALARM RANG DURING HANDPIECE TESTING. THE ALARM MESSAGE REQUESTED TO CHANGE THE HANDPIECE; THE MEDICAL STAFF CHANGED THE HANDPIECE, BUT THE ALARM RANG AGAIN. THEY CHANGED THE GENERATOR AND THE ALARM RANG AGAIN. THEY THEN CHANGED THE UNIT; THERE WAS NO ALARM, AND THE CUSA SYSTEM FUNCTIONED AS EXPECTED. THERE WAS NO CONSEQUENCE FOR THE PATIENT DURING SURGERY; HOWEVER, THERE WAS INCREASE OF SURGERY TIME OF 30-40 MINUTES. THE ADULT PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16322575 ↗
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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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