SurgiStat SURGII-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521035928), received between Sep 8, 2017 and Oct 19, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING USE, THE NURSE GOT MINOR BURN INJURY/RED SKIN AREA.

  Patient problems: Burn(s)

  MAUDE report 15634058 ↗
• MalfunctionSep 16, 2019Loose or Intermittent Connection; Inaccurate Delivery; Noise, Audible; Loose or Intermittent Connection; Inaccurate Delivery; Noise, Audible

  ACCORDING TO THE REPORTER, THE UNIT HAD A LOOSE FOLIE HANGING OUT AND A SPEAKER WITH CREAKING NOISE. RETURN ELECTRODE MONITORING(REM) TEST FAILED BY INCREASED RESISTANCE TO 20 OHM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 9072442 ↗
• MalfunctionSep 16, 2019Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, THE REM TEST FAILED BY INCREASING RESISTANCE TO 20 OHM.

  Patient problems: No Information

  MAUDE report 9071832 ↗
• MalfunctionJun 17, 2019Inaccurate Delivery; Failure to Calibrate; Inaccurate Delivery; Failure to Calibrate

  ACCORDING TO THE REPORTER, THE UNIT'S RETURN ELECTRODE MONITORING (REM) WAS OUT OF SPECIFICATION AS INCREASE RESISTANCE FROM 120 OHM UP TO 150 OHM, BUT ONLY TURNS RED AT 152 OHM.

  Patient problems: No Information

  MAUDE report 8705233 ↗
• MalfunctionMay 8, 2019Inaccurate Delivery; Device Displays Incorrect Message; Inaccurate Delivery; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, THE UNIT HAD AN ERROR CODE E6. THE UNIT MUST BE RESET. PATIENT RETURN ELECTRODE TEST FAILING AT: INCREASING RESISTANCE ALARM FROM 120 SHOULD TRIP BEFORE 150, DID NOT TRIP BEFORE 164. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8592176 ↗
• MalfunctionSep 28, 2018Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING SERVICING, THE UNIT HAD AN ERROR F3 WHICH REFERS TO HAVING ACTIVATED THE MONOPOLAR HANDLE WHEN THE EQUIPMENT WAS CONFIGURED FOR BIPOLAR ACTIVATIONS. THERE WAS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7919286 ↗
• MalfunctionJan 9, 2018Defective Alarm; Energy Output Problem; Defective Alarm; Energy Output Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S CURRENT WAS TOO HIGH CAUSING MAIN VOLTAGE TO FUSE AND WENT OUT. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE CENTER FOUND THE REM FAILED AS THE SIGNAL REMAINED GREEN BETWEEN 130 AND 140 OHMS.

  Patient problems: No Patient Involvement

  MAUDE report 7176806 ↗
• MalfunctionNov 28, 2017False Alarm; Defective Alarm; False Alarm; Defective Alarm

  ACCORDING TO THE REPORTER, THE DEVICE'S RETURN ELECTRODE MONITORING WAS FOUND OUT OF CALIBRATION. THE LIMIT FROM THE SERVICE MANUAL WAS 135 OHMS AND ACTUAL VALUE WAS >145 OHMS, A SCENARIO THAT COULD LEAD TO PATIENT HARM. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7062826 ↗
• MalfunctionSep 8, 2017Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, WHEN THE MONOPOLAR DEVICE ACTIVATION HAD ENDED, THE DEVICE CONTINUED TO ACTIVATE AT 3/50 FOR A FEW SECONDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6853533 ↗