SurgiStat SURGII-JRecalls & reported problems
Covidien LP · Electrosurgical Generator II,110 V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521041714), received between Jul 17, 2019 and Apr 29, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem1
- Energy Output Problem1
- Failure to Calibrate1
- Inaccurate Delivery1
- Self-Activation or Keying1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Energy Output Problem; Self-Activation or Keying; Communication or Transmission Problem; Energy Output Problem; Self-Activation or Keying; Communication or Transmission Problem
ACCORDING TO THE REPORTER, DURING SERVICING, WHEN TURNING THE CUT DIAL, THE COAG VALUE SWINGS UP AND DOWN. THE SAME THING WOULD HAPPEN EVEN IF THE COAG DIAL WAS TURNED. WHEN THE DIAL WAS STOPPED, THE NUMBERS WOULD STABILIZE. IT WAS OBSERVED THAT THE OUTPUT DISPLAY SWUNG UP AND DOWN WHEN THE DIAL WAS TURNED, SO THE DIAL WAS RETIGHTENED. DIALING CUTOFF. APPEARANCE AND FUNCTION INSPECTION, INDIVIDUAL LEAKAGE CURRENT TEST, OUTPUT TEST, PATIENT SAFETY CIRCUIT TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19205841 ↗MalfunctionJul 17, 2019Inaccurate Delivery; Failure to Calibrate; Inaccurate Delivery; Failure to Calibrate
ACCORDING TO THE REPORTER, PRIOR THE PROCEDURE, THE DEVICE EXCEEDED THE OUTPUT VALUES WERE DETECTED. SOLID PAD UPPER TRIP RESISTANCE IS 10 OHM. SPLIT PAD UPPER TRIP RESISTANCE IS 153 OHM. ALSO, RETURN ELECTRODE MONITORING(REM) TEST FAILED WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8800484 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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