Valleylab E6008LRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521766662), received between Sep 27, 2023 and Mar 26, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (8 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT POWER UP. AS A RESULT, THE PROCEDURE WAS STOPPED AND SUBSEQUENTLY ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 24698629 ↗
• InjuryAug 14, 2025Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE STOPPED WORKING. THE PROCEDURE WAS CANCELLED THAT DAY.

  Patient problems: Insufficient Information

  MAUDE report 22803706 ↗
• MalfunctionJul 3, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING HYSTERECTOMY, WHEN USING A NON MEDTRONIC MONOPOLAR DEVICE AND AFTER TIGHTENING AROUND THE CERVIX, THE FOOT PEDAL IN THE MONOPOLAR SYSTEM ACTIVATED INDEPENDENTLY WITHOUT IT BEING PRESSED BY THE SURGEON. IMMEDIATELY, THE DEVICE CONNECTIONS WERE REMOVED TO CHECK THAT THE DEVICE HAD NOT TOUCHED OTHER ORGANS IN THE ABDOMEN. THE FOOT PEDAL WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT ANY ISSUES. DURING HOSPITALIZATION, THE PATIENT FELT WELL AND WAS LEFT FOR OBSERVATION FOR A FEW MORE ADDITIONAL DAYS. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394118 ↗
• MalfunctionJan 6, 2025Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  IT WAS REPORTED THAT THE FOOTSWITCH HAD INCORRECT FUNCTIONALITY, WHERE THE FOOT PADDLE DESIGNATED FOR CUTTING (YELLOW) ACTIVATED COAGULATION, AND THE FOOT PADDLE DESIGNATED FOR COAGULATION (BLUE) ACTIVATED CUTTING. THIS ISSUE WAS IDENTIFIED BY A BIOMEDICAL ENGINEER DURING SERVICING IN THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081082 ↗
• MalfunctionSep 9, 2024Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PEDAL WAS PLUGGED IN AND IT JUST WENT OFF LIKE IT WAS BEING USED - NON STOP. THEY HAD TO UNPLUG IT AND PLUG IT BACK IN TO GET IT TO STOP. THEN IT DID NOTHING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169472 ↗
• MalfunctionSep 6, 2024Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING TESTING, WHEN CUT WAS ACTIVATED USING THE PEDAL, THE DISPLAY SHOWED COAGULATION AND VICE VERSA. CUSTOMER CONFIRMED IT WAS THE FOOT SWITCH AT FAULT BY CROSS CHECKING WITH ANOTHER FT10 GENERATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163006 ↗
• MalfunctionJun 4, 2024Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  ACCORDING TO THE REPORTER, THE DEVICE ENCOUNTERED INVERSION MODE BETWEEN YELLOW AND BLUE PEDAL. A TEST WAS PERFORMED WITH ANOTHER FOOT PEDAL AND NO PROBLEMS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462727 ↗
• MalfunctionApr 16, 2024Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING SERVICING AT THE FACILITY, WHEN STOOD ON THE YELLOW CUT PEDAL, DEVICE TRIGGERED COAG ON THE SCREEN. LIKEWISE, WHEN USED THE BLUE PEDAL, IT TRIGGERED CUT ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115941 ↗
• MalfunctionJan 9, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON PRESSED THE BLUE MONOPOLAR PEDAL TO PERFORM HEMOSTASIS, THE CUT WAS ACTIVATED ON THE PATIENT'S LIVER. THEY WANTED TO DO A COAGULATION FOLLOWING SLIGHT BLEEDING IN THE VICINITY OF THE GALLBLADDER. THE SURGEON SUPPORTED ON THE BLUE PEDAL. HE THEN TRIGGERED A CUT, CAUSING AN INCISION IN THE LIVER. THEY CONTINUED THE PROCEDURE BY TAKING ANOTHER SCALPEL. AFTER TESTING WITH THE BIOMEDICAL DEPARTMENT, THE PEDAL WAS IDENTIFIED AS THE SOURCE OF THE PROBLEM WITH A STRONG SUSPICION OF A REVERSAL IN THE INTERNAL WIRING OF THE PEDAL. THIS WAS A FAILURE OUT OF BOX. THERE WAS BLEEDING OF LESS THAN 250CC AND NO TRANSFUSION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Liver Laceration(s)

  MAUDE report 18480727 ↗
• MalfunctionSep 27, 2023Energy Output Problem; Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Energy Output Problem; Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DIATHERMY MACHINE COAGULATION/CUT MODULE WAS NOT RESPONDING EFFECTIVELY. IT WAS INTERMITTENT AND SOMETIMES DID THE OPPOSITE ACTIONS TO THE SIGNALS BEING SENT FROM THE PEDALS. SWAPPED OUT THE UNIT TO ANOTHER TO CONTINUE WITH THE OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 17825681 ↗