WECK 809319Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607151009809), received between Feb 15, 2019 and Jun 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Break

  THE DOCTOR WAS USING A WECK DISPOSABLE EXTENDED BLADE ELECTRODE. UPON INSPECTION BY THE SURGICAL TECH, A PORTION OF THE BOVIE TIP WAS NOT INTACT. THE BOVIE TIP WAS REPLACED AND USED WITHOUT FURTHER INCIDENT. BOTH THE BROKEN BOVIE AND THE REPLACEMENT BOVIE WERE RETAINED FOR INSPECTION. NO HARM CAME TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676297 ↗
• MalfunctionFeb 15, 2019Break

  WECK DISPOSABLE 6" EXTENDED 3/4" BLADE ELECTRODE WAS USED BY SURGEON. UPON INSPECTION BY SURGICAL TECH, A PORTION OF THE BOVIE TIP WAS NOT INTACT. BOVIE TIP WAS REPLACED AND USED WITHOUT FURTHER INCIDENT. BOTH THE BROKEN BOVIE AND THE REPLACEMENT BOVIE WERE RETAINED FOR INSPECTION. NO HARM CAME TO THE PATIENT. IMAGES OF THE BROKEN DEVICE WERE OBTAINED AND THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, WECK (PER SITE REPORTER). THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. ANY FURTHER UPDATES FROM THE MANUFACTURER WILL BE SHARED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342832 ↗