Valleylab E3781-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521767867), received between Feb 15, 2021 and Apr 25, 2023 — classified as 2 malfunctions.

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

• MalfunctionApr 25, 2023Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR SURGERY, WHILE PERFORMING THE INTESTINAL MEMBRANE PROCESSING, MAKING AN INTESTINAL INCISION, THERE WAS OUTPUT (POWER LEAKAGE) FROM THE TIP OF THE INSULATED PART OF THE DEVICE. THE FAT OF THE PATIENT WAS BURNED/CAUTERIZED, WITH A SIZE OF 1MM, THE DEGREE OF THE BURN COULD NOT BE MEASURED, BUT IT WAS AN INCISION SITE SO THERE WAS NO BLEEDING, AND SINCE IT WAS IN THE POSITION WHERE THE INCISION WAS PLANNED, NO TREATMENT WERE PERFORMED FOR THE BURN. THE DEVICE WAS USED WITH CARE TO COMPLETE THE SURGERY. THERE WAS NO ADHESION OF ESCHAR AND THE LIKE.

  Patient problems: Burn(s)

  MAUDE report 16811084 ↗
• MalfunctionFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INTERSPHINCTERIC RESECTION (ISR), THE CYLINDRICAL ELECTRODE WAS EXPOSED EXCEPT FOR THE TIP ELECTRODE PART. WHEN THE TIP OF THE ELECTRODE TOUCHED THE CYLINDRICAL PART, THE INTESTINE AND MESENTERY WERE BURNED BY ABOUT 1 CM AND THERE WAS NO NEED TO REPAIR.

  Patient problems: Bowel Burn

  MAUDE report 11327457 ↗