ZIP Pen 252510ECRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10614559105344), received between Jul 14, 2020 and Nov 30, 2023 — classified as 1 injury, 4 malfunctions.

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

• InjuryNov 30, 2023Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BURN PROCEDURE THAT THE BOVIE WAS SENDING ELECTRICAL CURRENT TO THE PENCIL DESPITE THE BUTTON ON THE BOVIE PEN NOT BEING PRESSED. THE SURGEON HEARD THE BOVIE SOUND AND ASKED THE RESIDENT IF THEY WERE BOVING- WHICH THEY WERE NOT. WHEN THE SURGEON LOOKED DOWN THE BOVIE WAS BARLEY TOUCHING THE PATIENT'S CALF AND DIDN'T HAVE ANYTHING PRESSING ON THE BUTTONS. WHEN HE RAISED IT UP THE BOVIE WAS STILL ACTIVATED. RESULTING IN A RIGHT CALF BURN, MEDIAL ASPECT, PROXIMAL TO ANKLE. BIOMED WAS CALLED AND THE "BOVIE BOX" WAS REMOVED FROM SERVICE FOR INSPECTION. THE SURGEON EXCISED THE FULL THICKNESS BURN AND DID A PRIMARY CLOSURE AND WRAPPED THE AREA IN KERLIX. A BOVIE HOLSTER WAS NOT IN USE AT THE TIME OF THE EVENT.

  Patient problems: Full thickness (Third Degree) Burn; Scar Tissue

  MAUDE report 18237062 ↗
• MalfunctionNov 9, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AN ARCING OF ELECTRODES OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761835 ↗
• MalfunctionSep 21, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS ARCING OF THE ELECTRODES. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PROBLEM NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461680 ↗
• MalfunctionJun 3, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING A DIEP FLAP PROCEDURE THERE WERE BIG SPARKS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14590618 ↗
• MalfunctionJul 14, 2020Fire; Fire

  IT WAS REPORTED THAT DURING A REVISION OF THE HIP, THE MEGADYNE EZ CLEAN ELECTRODE CAUGHT ON FIRE. IN THE 30 MINUTES BEFORE THE INCIDENT, THE SURGEON WAS CUTTING/COAGULATING SCARE TISSUE. HE SAID THE IMPEDANCE CHANGED AFTER THE SCARE TISSUE NEAR TO THE PROSTHESES. THE ELECTRODE CAME NEAR THE HIP PROSTHESIS AND THE COATING OF THE ELECTRODE OR THE ELECTRODE ITSELF CAUGHT ON FIRE. THE FLAME WAS FIVE CENTIMETRES TALL AND LASTED FOR A FEW SECONDS. THE BENT CORNER WAS DUE TO THE HEAT. THIS WAS NOT BENT ON PURPOSE. THE PROCEDURE WAS DONE ON AN ERBE VIO 300D GENERATOR WITH THE SETTINGS ON DRY EFFECT 4 180 WATT AND FORCED COAG EFFECT 3 80 WATT. THIS IS THE STANDARD PROGRAM FOR THE ORTHOPEDIC SURGEONS IN THIS HOSPITAL. THE DOCTOR CLEANED THE BLADE OFTEN WITH WET GAUSE. THE PATIENT RETURN ELECTRODE PAD WAS A 3M 9160F. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273500 ↗