Valleylab E2608-6 (UDI 20884521039015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521039015), received between Nov 12, 2020 and Apr 9, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2025Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ENT (EAR, NOSE, AND THROAT) OPERATION, THE TWO DEVICES' TIPS WERE ROTATING AND GETTING STUCK. AS A RESULT, THE OPERATING SURGEON'S HAND WAS BURNED. THE TWO DEVICES WERE REPLACED IN ORDER TO COMPLETE THE CASE.

  Patient problems: Burn(s)

  MAUDE report 21808550 ↗
• MalfunctionApr 9, 2025Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ENT (EAR, NOSE, AND THROAT) OPERATION, THE TWO DEVICES' TIPS WERE ROTATING AND GETTING STUCK. AS A RESULT, THE OPERATING SURGEON'S HAND WAS BURNED. THE TWO DEVICES WERE REPLACED IN ORDER TO COMPLETE THE CASE.

  Patient problems: Burn(s)

  MAUDE report 21808334 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE SUCTION CAUTERY BURNED AND CAME OFF, CAUSING NECESSARY TO OPEN A NEW ONE. NO PIECE FELL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066239 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN ADENOID REDUCTION PROCEDURE, PATIENT SUSTAINED A PARTIAL THICKNESS SKIN BURN ON THE LIP DURING THE PROCEDURE. AN INCIDENT WHICH HAPPENED FOR ONE OF PEDIATRIC PATIENT FEW WEEKS AGO DUE TO POTENTIALLY DAMAGED MONOPOLAR SUCTION COAGULATOR. THE SURGEON CONFIRMED THAT THERE WAS NO NOTICEABLE BURN IN THE IMMEDIATE POST OP BUT IT GRADUALLY DEVELOPED WHICH MADE THE SURGEON TO SUSPECT THAT THERE WAS A FAULT IN THE INSULATION. THE SURGEON CONFIRMED THAT HE HAD TO REFER THE PATIENT TO A PLASTIC SURGEON AND IS UNDER TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 10827764 ↗