Valleylab E1551XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521713314), received between Aug 2, 2017 and Jul 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2022Fire; Melted; Fire; Melted

  ACCORDING TO THE REPORTER, DURING USE OF THE ELECTROCAUTERY IN COAGULATION MODE, THE TIP FLAMED AND MELTED. THE ELECTRIC KNIFE WAS SET TO 5 AND 8 FOR COAGULATION. THE SURGEON IMMEDIATELY REALIZED THIS AND STOPPED HIS SURGICAL PROCEDURE. ACTION TAKEN WAS CHANGING THE TIP OF THE ELECTRIC KNIFE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047860 ↗
• MalfunctionAug 2, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE BLADE BROKE DURING SURGERY. THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER HAS NOT FOUND THE PIECE OF BLADE BUT STATE THAT IT IS NOT WITHIN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759384 ↗