Valleylab E3771-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521548992), received between Apr 12, 2023 and Mar 12, 2025 — classified as 2 malfunctions.

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

• MalfunctionMar 12, 2025Inappropriate/Inadequate Shock/Stimulation; Electrical Shorting; Inappropriate/Inadequate Shock/Stimulation; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR SURGERY FOR PERITONEAL INCISION, THE ELECTRODE HAD SHORT CIRCUIT/LEAKAGE OF ELECTRICITY. THE PATIENT TWITCHED WHEN THE ELECTRODE WAS ACTIVATED (MEANS THAT THERE WAS AN NEUROSTIMULATION). REPLACED WITH ANOTHER DEVICE, AND IT WORKED FINE.

  Patient problems: Electric Shock

  MAUDE report 21584339 ↗
• MalfunctionApr 12, 2023Contamination; Peeled/Delaminated; Contamination; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE PACKAGE WAS OPENED AT THE PREPARATION STAGE BEFORE THE START OF SURGERY, THERE WAS A DIRT FOUND ON THE SHAFT PART AND STICKING TO IT. THERE WAS NO PATIENT INVOLVEMENT. THE MEDTRONIC INITIAL VISUAL INSPECTION FOUND OUT MINOR DAMAGE TO THE INSULATION OF THE DEVICE. THE DAMAGE TO THE INSULATION IS CONSISTENT WITH BURN DAMAGE. MOST LIKELY FROM COMING INTO CONTACT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723948 ↗