SurgiStat VLSURGGENRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521517417), received between Jul 18, 2019 and Jul 31, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Inaccurate Delivery; Connection Problem; Adverse Event Without Identified Device or Use Problem; Inaccurate Delivery; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AN INSPECTION WAS REQUESTED FOR POSSIBLE BURNS ALONG THE EDGE PART OF THE RETURN ELECTRODE. TWO WEEKS AFTER THE SURGERY, IT BECAME CLEAR THAT THE HAIR HAD FALLEN OUT AND BECAME LIKE A KELOID WHEN THE VISIT TO THE HOSPITAL WAS DONE FOR SUTURE REMOVAL. THE RETURN ELECTRODE WAS BEING REUSED. CASE WAS USED ON VETERINARY CLINIC. THERE WAS NO PATIENT INVOLVEMENT. FROM (B)(4): ACCORDING TO THE REPORTER, 2 WEEKS AFTER THE SURGERY, THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR SUTURE REMOVAL AND IT WAS NOTED THAT THE RETURN ELECTRODE SITE BECAME KELOID-LIKE (FIRST DEGREE BURN). THE KELOID WAS NOT CONFIRMED DURING AND IMMEDIATELY AFTER THE PROCEDURE DUE TO THE ANIMAL'S FUR. NO TREATMENT WAS PROVIDED. IT WAS NOTED DURING CONDITION CHECKING THAT THE PEDIATRIC RETURN ELECTRODE WAS REUSED AND A GEL WAS APPLIED ON THE ELECTRODE PART AND THE ALARM OF THE RETURN ELECTRODE CONTACT STATUS MONITORING SYSTEM DID NOT SOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 17431261 ↗
• MalfunctionJan 30, 2023Energy Output Problem; Inaccurate Delivery; Connection Problem; Energy Output Problem; Inaccurate Delivery; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT'S MONOPOLAR OUTPUT WAS WEAK. RETURN ELECTRODES INDICATOR LIT IN GREEN WHILE THE RETURN ELECTRODES NOT CONNECTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265023 ↗
• MalfunctionApr 15, 2020Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS NO ALARM WHEN DEVICE MEASURES 0 OHM ON THE RETURN ELECTRODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9961015 ↗
• MalfunctionMar 31, 2020High Readings; Adverse Event Without Identified Device or Use Problem; High Readings; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S OUTPUT WAS TOO HIGH. THE VETERINARIAN WAS BURNT.

  Patient problems: Burn(s)

  MAUDE report 9902212 ↗
• MalfunctionJan 30, 2020Inaccurate Delivery; Device Displays Incorrect Message; Inaccurate Delivery; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD AN ERROR CODE E4 AND FAILING RETURN ELECTRODE MONITORING (REM) TEST. DURING THE REM TEST THE UNIT DID NOT ALARM AT THE MINIMUM 3 OHM VALUE THAT IS SHOULD HAVE ALARMED AT. IT DID NOT ALARM UNIT ZERO OHMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9647736 ↗
• MalfunctionJul 18, 2019Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE REPORTER, THE DEVICE HAD RETURN ELECTRODE MONITOR(REM) TESTING FAILED BY DECREASE RESISTANCE TO ALARM .

  Patient problems: No Information

  MAUDE report 8803562 ↗