WECK IPN029475Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704646026), received between Apr 8, 2021 and May 15, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Melted” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Melted; Melted

  IT WAS REPORTED THAT "DURING A CASE ON A PATIENT, THE STAFF NOTICED THAT THE ELECTRODE STARTED TO 'MELT', THEY TRIED ANOTHER ELECTRODE WHERE THEY NOTICED THE SAME ISSUE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED ON 16 MAY 2023 STATES THAT A 4TH ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. "THE FIRST TIP WAS USED FOR ABOUT 30 SECONDS AND IT BEGAN TO MELT. THE SECOND TIP WAS USED FOR JUST A FEW SECONDS AND BEGAN TO MELT. THE THIRD TIP (FIRE) LIT IMMEDIATELY UPON ACTIVATION." THE 4TH ELECTRODE WAS FROM A DIFFERENT LOT NUMBER THAN THE ONES THAT ISSUES OCCURRED WITH. THE PROCEDURE BEING PERFORMED WAS A VAGINAL POSTERIOR REPAIR, THERE WAS NO TISSUE OR ESCHAR BUILDUP ON THE ELECTRODE AS THE ELECTRODE WAS USE AT THE BEGINNING OF THE PROCEDURE, THERE WAS NO FACIAL/BODY HAIR. NORMAL ANESTHETIC GASSES WERE USED FOR GENERAL ANESTHESIA. THE CUSTOMER WAS UNSURE WHAT VOLTAGE WAS BEING USED WHEN THE ISSUE OCCURRED. ASSOCIATED MDRS: 3011137372-2023-00130, 3011137372-2023-00131.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932236 ↗
• MalfunctionMay 15, 2023Melted; Melted

  IT WAS REPORTED THAT "DURING A CASE ON A PATIENT, THE STAFF NOTICED THAT THE ELECTRODE STARTED TO 'MELT', THEY TRIED ANOTHER ELECTRODE WHERE THEY NOTICED THE SAME ISSUE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED ON 16 MAY 2023 STATES THAT A 4TH ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. "THE FIRST TIP WAS USED FOR ABOUT 30 SECONDS AND IT BEGAN TO MELT. THE SECOND TIP WAS USED FOR JUST A FEW SECONDS AND BEGAN TO MELT. THE THIRD TIP (FIRE) LIT IMMEDIATELY UPON ACTIVATION." THE 4TH ELECTRODE WAS FROM A DIFFERENT LOT NUMBER THAN THE ONES THAT ISSUES OCCURRED WITH. THE PROCEDURE BEING PERFORMED WAS A VAGINAL POSTERIOR REPAIR, THERE WAS NO TISSUE OR ESCHAR BUILDUP ON THE ELECTRODE AS THE ELECTRODE WAS USE AT THE BEGINNING OF THE PROCEDURE, THERE WAS NO FACIAL/BODY HAIR. NORMAL ANESTHETIC GASSES WERE USED FOR GENERAL ANESTHESIA. THE CUSTOMER WAS UNSURE WHAT VOLTAGE WAS BEING USED WHEN THE ISSUE OCCURRED. ASSOCIATED MDRS: 3011137372-2023-00128, 3011137372-2023-00130, 3011137372-2023-00131.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932125 ↗
• MalfunctionMay 12, 2023Melted; Melted

  IT WAS REPORTED THAT PRIOR TO USE IN THE CLINICAL SETTING, "AFTER 2 ELECTRODES MELTED" AN ADDITIONAL ELECTRODE FROM A NEW PACKAGE WAS USED AND IT "EMITTED A FLAME". NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED ON 16 MAY 2023 STATES THAT A 4TH ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. "THE FIRST TIP WAS USED FOR ABOUT 30 SECONDS AND IT BEGAN TO MELT. THE SECOND TIP WAS USED FOR JUST A FEW SECONDS AND BEGAN TO MELT. THE THIRD TIP (FIRE) LIT IMMEDIATELY UPON ACTIVATION." THE 4TH ELECTRODE WAS FROM A DIFFERENT LOT NUMBER THAN THE ONES THAT ISSUES OCCURRED WITH. THE PROCEDURE BEING PERFORMED WAS A VAGINAL POSTERIOR REPAIR, THERE WAS NO TISSUE OR ESCHAR BUILDUP ON THE ELECTRODE AS THE ELECTRODE WAS USE AT THE BEGINNING OF THE PROCEDURE, THERE WAS NO FACIAL/BODY HAIR. NORMAL ANESTHETIC GASSES WERE USED FOR GENERAL ANESTHESIA. THE CUSTOMER WAS UNSURE WHAT VOLTAGE WAS BEING USED WHEN THE ISSUE OCCURRED. ASSOCIATED MDRS: 3011137372-2023-00128, 3011137372-2023-00130.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923878 ↗
• MalfunctionApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECOND DEGREE BURN ORAL COMMISSURE. INSULATED BOVIE ELECTRODE NEEDLE INSERTED INTO BOVIE COVIDIEN PENCIL, DESPITE INCOMPLETE INSERTION OF THE BOUNCE ELECTRODE IN THE BOVIE PENCIL A COMPLETE CIRCUIT EXISTED. LIMITED TOPICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633201 ↗