Valleylab E2504HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884524001616), received between Nov 20, 2018 and Nov 20, 2018 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LOOP ELECTROSURGICAL EXCISION PROCEDURE(LEEP), THE NURSE PLUGGED THE CAUTERY PENCIL INTO GENERATOR WITHOUT ANY ISSUES OR ERROR MESSAGE. ANOTHER BRAND OF ELECTRODE WAS INSERTED INTO THE PENCIL. WHEN THE PHYSICIAN ACTIVATED THE CAUTERY UNIT VIA FOOT PEDAL THE FILAMENT ON THE ELECTRODE SNAPPED WHILE ATTEMPTING TO EXCISE TISSUE FROM THE PATIENT. THE BROKEN ELECTRODE WAS DISCARDED AND NEW ELECTRODE WAS ATTACHED TO THE PENCIL. THE ISSUE PERSISTED. A THIRD ELECTRODE WAS BROUGHT INTO THE ROOM AND ATTACHED TO THE PENCIL. STAFF OBSERVED, WITHOUT USING THE DEVICE ON THE PATIENT WHEN THE FOOT PEDAL WAS USED TO ACTIVATE THE DEVICE THE ELECTRODE VISIBLY OVERHEATED AND SNAPPED. A NEW CAUTERY PENCIL WAS BROUGHT INTO THE ROOM AND NEW ELECTRODE WAS ATTACHED AND THERE WERE NO FURTHER ISSUES OCCURRED.

  Patient problems: No Information

  MAUDE report 8091964 ↗