WECK IPN919100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704736086), received between Sep 7, 2023 and Jul 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Sparking; Sparking

  IT WAS REPORTED VIA MEDWATCH "IT WAS REPORTED THAT "DURING THE PROCEDURE, THE TELEFLEX NEEDLE ELECTRODE TIP WAS NOTED TO HAVE A LARGE SPARK, THE SETTING WAS AT 60, THE STAFF LOWERED TO 40; IT STILL HAD A SPARK. TELEFLEX TIP THEN SWITCHED OUT WITH NO RESOLUTION. THE BOVIE PENCIL, BOVIE TIP AND BOVIE MACHINE WAS CHANGED OUT AND MEGADYNE PAD NOT USED. A BOVIE PAD PLACED; HOWEVER, THE SURGEONS DID NOT NEED TO BOVIE ANYMORE, SO NOT SURE IF THAT RESOLVED THE ISSUE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "N/A. BOVIE SPARK DID NOT IMPACT THE PATIENT'S CONDITION". ADDITIONAL INFORMATION ALSO STATES THAT THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733929 ↗
• InjurySep 7, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE "BOVIE TIP HAD A HOLE IN THE INSULATION, AND CAUSED A BURN TO THE PATIENT'S SKIN. BOVIE TIP REMOVED FROM FIELD AND REPLACED. WOUND DEBRIDED AND COVERED WITH PETROLATUM JELLY". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Burn(s)

  MAUDE report 17700685 ↗