ZIP Pen 252510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559105337), received between Dec 14, 2019 and Dec 31, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 31, 2024Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT THEY WERE REMOVING A LESION/CYST FROM THE PATIENTS NECK AT A AMBULATORY SURGERY SITE. WHEN THE UNIT WAS BEING ACTIVATED THE STERILE DRAPES CAUGHT FIRE AND THE FIRE SPREAD TO THE PATIENT. THEY PUT THE FIRE OUT AND PATIENT WAS TAKEN TO LOCAL ER BY AMBULANCE, PATIENT SUSTAINED BURNS. THAT IS ALL THE INFORMATION KNOWN TO THE BIOMED AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 21047099 ↗
• MalfunctionOct 5, 2023Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A BIOPSY THAT A FIRE BALL CAME OUT OF PENCIL. THEY SWITCHED OUT TIP TO MEDTRONIC. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875907 ↗
• InjuryMar 14, 2022Flaked; Material Separation; Flaked; Material Separation

  IT WAS REPORTED THAT DURING A INGUINAL HERNIA REPAIR, THE EZ-CLEAN COATING PARTIALLY DETACHED FROM THE ELECTRODE. IT WAS DURING THE TEST WITH SMOKE EVACUATOR PENCIL. PART OF THE PROCEDURE WAS TUNNELED, IT CAN NOT BE EXCLUDED THAT THE POSSIBILITY THAT THE PHYSICIAN TOUCHED THE ELECTRODE WITH A METAL INSTRUMENT. THE ELECTRODE WAS ONLY CLEANED WITH A DAMP CLOTH (NO ABRASIVE SPONGE OR KNIFE). THE CUSTOMER IS FAMILIAR WITH EZ-CLEAN ELECTRODES. HE HAS BEEN USING THEM FOR SEVERAL YEARS (VERSION 0012M). HE HAS NEVER EXPERIENCED THIS BEFORE. DISADVANTAGES TO THE PATIENT INCLUDED SURGICAL TIME INCREASED BY 10 MINUTES. THE COATING PARTICLES COULDN¿T ALL BE REMOVED AND ARE THEREFORE STILL IN THE INGUINAL CANAL OF THE PATIENT. THE ELECTRODE WAS IMMEDIATELY REMOVED FROM THE SURGICAL FIELD PICTURES WERE TAKEN OF THE PARTICLES JUST AFTER REMOVAL AND IN THE PATIENT. A NEW SMOKE EVACUATOR PEN WITH THE SAME REFERENCE AND LOT NUMBER WAS USED TO FINISH THE PROCEDURE. THE EZ-CLEAN ELECTRODE OF THIS PEN SHOWED NO PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 13757690 ↗
• MalfunctionDec 14, 2019Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BOVIE PENCIL WAS LAID ON THE DRAPE AND IT BURNED A HOLE IN IT. THIS WAS NEAR THE PATIENT'S FACE. THE TIP WAS CHANGED, AND THE PROCEDURE WAS CONTINUED. THE BOVIE WAS LAID ON THE DRAPE BELOW THE PATIENT¿S FEET AND IT BURNED A HOLE IN IT AS WELL. THE PATIENT WAS NOT BURNED, AND THE CUT WAS SET ON 35 AND THE COAG WAS ALSO SET ON 35.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470635 ↗