Valleylab E3305 (UDI 10884524002026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524002026), received between Oct 13, 2017 and Aug 17, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (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.

• MalfunctionAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUCTION BOVIE METAL WAS EXPOSED AND BURNT THE PATIENT'S LIP.

  Patient problems: Burn(s)

  MAUDE report 12332981 ↗
• MalfunctionOct 13, 2017Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE BUTTON ON THE DEVICE WHICH ALLOWS YOU TO SUCTION OR COAGULATE STAYS IN COAGULATE MODE. THE ISSUE RESULTED IN UNINTENDED BURNING OF TISSUE.

  Patient problems: No Information

  MAUDE report 6950012 ↗