Valleylab E2516HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001500), received between Jul 10, 2018 and Jul 31, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 31, 2018Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BLUE PLASTIC PART THAT CONNECTS THE METAL OF THE BOVIE PENCIL TO THE WHITE PART OF THE PENCIL LIT ON FIRE LIKE A LIGHTER FLAME. THE DOCTOR BLEW THE FLAME OUT AND OPENED A NEW PENCIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7735631 ↗
• MalfunctionJul 10, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE IN TWO PIECES. NOTHING FELL INTO PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674449 ↗