Valleylab E2781-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524000404), received between Jun 27, 2016 and Oct 9, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K964175); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, WHEN PERFORMING OPERATION IN THE PELVIS WITH A DEVICE, ACTIVATION WAS NOT OUTPUT FROM THE ELECTRODE, BUT FROM THE HANDPIECE PART, AND THE TISSUE GOT BURNED. THEY REPLACED IT WITH A NEW ONE, BUT THE SITUATION DID NOT CHANGE AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: Bowel Burn; Burn(s)

  MAUDE report 10659643 ↗
• MalfunctionSep 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION, THE TIP OF THE ELECTRODE BROKE OFF. THE DISENGAGED PART WAS RETRIEVED. NOTHING FELL INTO PATIENT'S CAVITY. SURGERY TIME WAS NOT EXTENDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084987 ↗
• MalfunctionJul 24, 2018Peeled/Delaminated; Therapy Delivered to Incorrect Body Area; Arcing; Sparking; Peeled/Delaminated; Therapy Delivered to Incorrect Body Area; Arcing

  ACCORDING TO THE REPORTER, DURING ABDOMINOPERINEAL RESECTION AND LAPAROSCOPY, SPARK WAS DISCHARGED FROM THE DISTAL END OF THE SHAFT OF THE DEVICE. ALSO THERMAL SPREAD WAS TOO MUCH, BUT NO TISSUE DAMAGE NOTED. A NEW DEVICE WAS OPENED TO CONTINUE THE PROCEDURE. OPERATING TIME NOT EXTENDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7715638 ↗
• MalfunctionApr 20, 2018Break; Detachment Of Device Component; Overheating of Device; Break; Detachment Of Device Component; Overheating of Device

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SHAFT OF THE DEVICE BECOMES ABNORMALLY HOT WHILE IN USE. THE DEVICE WAS CLEANED A FEW TIMES BUT THEN THE ELECTRODE TIP BROKE WHILE CLEANING. A NEW DEVICE WAS OPENED TO CONTINUE THE PROCEDURE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7448005 ↗
• MalfunctionMar 28, 2018Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE WAS USED WITH ANOTHER INSTRUMENT, AND COAG SPRAY WAS USED AT 30W. WHILE DISSECTING MESENTERY, ENERGY OUTPUT WAS DISTRIBUTED FROM THE EDGE OF THE SHAFT, NOT FROM THE ELECTRODE, AND MESENTERY WAS PARTIALLY CAUTERIZED. THE INSULATION SEEMED SHORTER THAN THE ELECTRODES USUALLY USED, AND THE METAL ELEMENT SEEMED TO BE EXPOSED MORE THAN OTHER DEVICES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378987 ↗
• MalfunctionJun 27, 2016Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING THE LAPAROSCOPIC PROCEDURE THERE WAS POWER DISTRIBUTION FROM THE SHAFT OF THE DEVICE. THERMAL SPREAD WAS NOTICED ON THE TISSUE IN CONTACT WITH THE SHAFT. ANOTHER DEVICE WAS OPENED AND IT WORKED FINE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5752707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964175. One submission often covers many models, so check the product and lot details in each record.

• Z-1836-2017 · Jan 26, 2017 · Terminated
  Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm ada