Valleylab E0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884524001774), received between Sep 22, 2017 and Feb 15, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fire” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2026Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE REUSABLE NON-MEDTRONIC SUCTION DIATHERMY WAS NOT WORKING PROPERLY. THE DIATHERMY MACHINE USED WAS THE DEVICE THEN THEY TRANSFERRED IT TO A NON-MEDTRONIC DIATHERMY MACHINE. THEY TRIED TO DISCONNECT AND CHECKED THE DIATHERMY EXTENSION LEAD AND WHILE DOING SO, THE USER RECEIVED A TINY/SMALL ELECTRICAL BURN IN THE RIGHT-HAND RING FINGER.

  Patient problems: Burn(s)

  MAUDE report 24341657 ↗
• MalfunctionOct 29, 2020Thermal Decomposition of Device

  A LAPAROSCOPIC MONOPOLAR CORD WAS DISCOVERED TO HAVE BURNED THROUGH THE CONNECTING END WHERE IT PLUGS INTO A ROBOTIC MONOPOLAR SCISSOR. THE RESIDENT AT BEDSIDE NOTED THAT IT WAS HOT TO THE TOUCH, AND UPON INSPECTION THE END OF THE CORD HAD A BLACKENED BURNT END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10754989 ↗
• MalfunctionMar 18, 2020Fire; Material Integrity Problem; Fire; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC PROSTATE SURGERY, THE CORD SPARKED AND CAUGHT FIRE. PICTURES WERE SUBMITTED WHICH SHOWED THE BURNT CORD. THE FIRE WAS PUT OUT BY THE NURSE PUTTING THE CORD IN THE PLASTIC HOLDER. THE PROCEDURE WAS COMPLETED USING A NEW OPENED CORD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847150 ↗
• MalfunctionNov 20, 2017Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THERE WAS A HOLE IN THE CORD INSULATION, EXPOSING THE INNER WIRES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047756 ↗
• InjurySep 22, 2017Fire; Overheating of Device

  ON (B)(6) 2017 DURING AN UNEVENTFUL LAPAROSCOPIC CHOLECYSTECTOMY IN THE MAIN OPERATING ROOM, A FLAME WAS NOTED WHILE USING A COVIDIEN VALLEYLAB LAPAROSCOPIC SINGLE-USE/DISPOSABLE MONOPOLAR CAUTERY CORD ((B)(4)). THE FLAME OCCURRED NEAR THE JUNCTION WHERE THE CORD CONNECTS TO THE CAUTERY INSTRUMENT. THE RESIDENT SURGEON'S GLOVE WAS BURNED AND HE SUSTAINED A FIRST DEGREE BURN TO THE HAND. THE PT WAS NOT HARMED. THE EQUIPMENT WAS IMMEDIATELY SEQUESTERED AND SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. WE ARE AWARE OF AT LEAST ONE OTHER MEDICAL CENTER THAT HAS HAD OVERHEATING ISSUES WITH THIS CAUTERY CORD. WE HAVE NOW DISCONTINUED THE USE OF THIS CORD AND HAVE SWITCHED TO A DIFFERENT CORD FROM A DIFFERENT MFR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 6886534 ↗