Valleylab E6009Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884524000381), received between Oct 12, 2017 and Jan 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, THE BIPOLAR FOOTSWITCH WAS STICKING AND DID NOT SHUT OFF AFTER FOOT WAS OFF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265537 ↗
• MalfunctionMay 20, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS CONNECTED TO THE UNIT FOR THE INSPECTION IMMEDIATELY AFTER DELIVERY, THE OUTPUT SOUND WAS GENERATED BY ITSELF EVEN WITHOUT STEPPING ON IT. THE UNIT OPERATED NORMALLY WHEN ANOTHER DEVICE WAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356364 ↗
• MalfunctionApr 9, 2024Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CHOLECYSTECTOMY SURGERY, THE HEAD NURSE REPORTED THAT THE NO. 2 ELECTROSURGICAL GENERATOR DEVICE CURRENTLY USED OCCASIONALLY EXPERIENCED NO RESPONSE TO THE FOOT PEDAL, WHICH WOULD AFFECT THE OPERATION. IF THE FOOT PEDAL CONNECTION CABLE WAS FIXED IN ONE DIRECTION, IT COULD BE USED NORMALLY. THE DEPARTMENT HAD PREPARED EMERGENCY BACKUP ELECTROSURGICAL GENERATOR AS AN EMERGENCY RESPONSE. AND CONTACTED THE EQUIPMENT DEPARTMENT PERSONNEL TO ARRIVE AT THE SCENE AND WAITED FOR MAINTENANCE AFTER THE OPERATION. AFTER THE EQUIPMENT DEPARTMENT STAFF ARRIVED AT THE SCENE IN TIME, THEY FOUND THAT THE CONNECTION CABLE AT THE ROOT OF THE GENERATOR FOOT PEDAL HAD POOR CONTACT. THEN CUT OFF THE CONNECTION LINE AT THE ROOT OF THE PEDAL AND RE-WELDED AND REINFORCED IT, THEN THE PEDAL COULD BE USED NORMALLY. ADVERSE EVENT REPORTED WAS ELECTRIC SHOCK.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 19076459 ↗
• MalfunctionDec 5, 2023Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, AS SOON AS THE FOOTSWITCH WAS CONNECTED TO GENERATOR, SELF ACTIVATION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267336 ↗
• MalfunctionOct 4, 2022Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE ON WHIPPLE PROCEDURE, THE UNIT¿S BIPOLAR AUTOMATICALLY ACTIVATING AND THE FOOTSWITCH WAS AUTOMATICALLY ACTIVATING INTERMITTENTLY WITHOUT PRESSING IT. THE SAME FOOTSWITCH WAS TESTED WITH OTHER MACHINE BUT THE PROBLEM REMAIN SAME. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537528 ↗
• MalfunctionAug 3, 2022Self-Activation or Keying; Insufficient Device Problem Information; Self-Activation or Keying; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS AUTOMATICALLY ACTIVATED WITHOUT PRESSING IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161602 ↗
• MalfunctionOct 12, 2017Device Remains Activated; Component Missing; Device Remains Activated; Component Missing

  THE CUSTOMER REPORTED THAT THE DEVICE WAS CAUSING THE GENERATOR TO CONTINUOUSLY ACTIVATE. THERE IS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6945500 ↗