AVID TruCustom VARV043-05_0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10809160205099), received between Jun 10, 2021 and Jun 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Disconnection; Disconnection

  COMPLAINT # (B)(4) CAUTERY PIECE BROKE OFF DURING SURGICAL PROCEDURE. THIS IS THE 3RD INCIDENT THAT OCCURRED WITH THE BOVIE. THE BROKEN CAUTERY DID NOT FALL INTO THE SURGICAL SITE. IT DID NOT INCREASE SURGERY TIME. THE NURSING TEAM HAD TO REPLACE THE BOVIE. AVID MEDICAL RECEIVED A COMPLAINT ON 06/08/2021, STATING THAT WHILE USING THE BOVIE SUCTION, THE SUCTION PIECE BROKE OFF DURING THE PROCEDURE. THE CUSTOMER STATED THAT THE BOVIE FUNCTIONED WELL DURING MOST OF THE CASE, BUT FAILED AFTER SEVERAL HOURS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040642 ↗
• MalfunctionJun 10, 2021Disconnection; Disconnection

  AVID MEDICAL REPORTED COMPLAINT # (B)(4) THAT A CAUTERY PIECE BROKE OFF AND FELL ONTO THE SURGERY WOUND. TWO EVENTS/BOTH HAD THE SAME MANUFACTURING LOT NUMBER/ SAME AVID KIT LOT NUMBER. WHILE USING THE CAUTERY IN THE STANDARD MANNER, THE CLEAR SUCTION PIECE FELL OFF IN THE FIELD AND APPEARS TO HAVE CRACKED. PER DR. (B)(6) STATED, THE BROKEN PIECE OF EACH BOVIE PEN FELL INTO THE SURGICAL WOUND (ONE CASE WAS A BREAST REDUCTION AND THE OTHER CASE WAS A BREAST RECONSTRUCTION CASE. NEITHER THE PATIENT NOR PERSONNEL WERE HARMED. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980169 ↗
• MalfunctionJun 10, 2021Disconnection; Disconnection

  AVID MEDICAL REPORTED COMPLAINT # (B)(4) THAT A CAUTERY PIECE BROKE OFF AND FELL ONTO THE SURGERY WOUND. TWO EVENTS/BOTH HAD THE SAME MANUFACTURING LOT NUMBER/ SAME AVID KIT LOT NUMBER. WHILE USING THE CAUTERY IN THE STANDARD MANNER, THE CLEAR SUCTION PIECE FELL OFF IN THE FIELD AND APPEARS TO HAVE CRACKED. PER (B)(6) STATED, THE BROKEN PIECE OF EACH BOVIE PEN FELL INTO THE SURGICAL WOUND (ONE CASE WAS A BREAST REDUCTION AND THE OTHER CASE WAS A BREAST RECONSTRUCTION CASE. NEITHER THE PATIENT NOR PERSONNEL WERE HARMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980147 ↗