PenEvac1 ICM-000-0572Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817688022527), received between Jul 7, 2026 and Jul 7, 2026 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026

  DURING SURGICAL PROCEDURE IN OR, SURGEON PLACED SUCTION BOVIE BACK IN HOLSTER. THE BOVIE PENCIL TUBING RECOILED, CAUSING IT TO COME OUT. DRAPES REMOVED. PT ASSESSED. CODE RED CALLED. FIRE ALARM PULLED. AFTER EVENT CLEARED, SURGICAL PROCEDURE PROCEEDED. DRAPE & BOVIE SAVED. IT HAS BEEN IDENTIFIED THAT AFTER THE TUBING SURROUNDING THE HOT CAUTERY TIP WAS PLACED INSIDE THE SAFETY HOLSTER IS RECOILED BACK AND OUT OF THE HOLSTER LANDING ON THE DRAPE CAUSING A BURN. ALTHOUGH THIS WAS QUICKLY IDENTIFIED, THE PATIENT WAS NEGATIVELY IMPACTED AND PLACED AT INCREASED RISK FOR SSI [SURGICAL SITE INFECTION] AS THE DRAPES HAD TO BE REMOVED AND REPLACED OVER A SURGICALLY OPENED JOINT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25734877 ↗