Valleylab E6008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001654), received between Feb 15, 2023 and May 27, 2026 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 27, 2026Failure to Deliver Energy; Device Remains Activated

  IT WAS REPORTED THAT DURING CYSTOSCOPY AND BLADDER RESECTION PROCEDURE, THE MONOPOLAR FOOTSWITCH COAGULATION PEDAL WOULD NOT RELEASE WHEN SURGEON'S FOOT WAS REMOVED FROM DEPRESSING IT. THE FOOT PEDAL WHICH WAS ATTACHED TO THE MONOPOLAR RESECTING LOOP WAS STILL IN PATIENT'S BLADDER CONTINUED TO COAGULATE INSIDE THE PATIENT. SURGEON QUICKLY REALIZED WHAT OCCURRED AND REMOVED THE LOOP FROM THE PATIENT TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296516 ↗
• MalfunctionFeb 15, 2023Unintended Power Up; Unintended Power Up

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE FOOT PEDAL'S MONOPOLAR CUT STAYED HOOKED WHEN PRESSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378447 ↗