EM3 Monopolar Adapter, Universal EM3-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10815288012983), received between Sep 21, 2020 and Sep 23, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Sparking” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 23, 2024Melted; Sparking; Melted; Sparking

  THE EM3-60 CABLE, WHICH IS CONNECTED TO THE ESU AND AEM MONITOR, BURNED IN THE OPERATING ROOM DURING SURGERY. THERE WERE NO INJURIES TO PATIENTS OR USERS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278381 ↗
• MalfunctionMay 31, 2023Melted; Sparking; Melted; Sparking

  THE EM3-60 CABLE, WHICH IS CONNECTED TO THE ESU AND AEM MONITOR, BURNED IN THE OPERATING ROOM DURING SURGERY. THERE WERE NO INJURIES TO PATIENTS OR USERS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030528 ↗
• MalfunctionNov 23, 2021Sparking; Sparking

  THE EM3-60 CABLE ADAPTER DISPLAYED BURNED OUTER INSULATION, INDICATING THE WIRE MAY HAVE BROKE AND BURNED THROUGH THE INSULATION. THE CABLE SPARKED IN THE OPERATING ROOM. THE LOCATION OF THE FAILURE OCCURED ON THE FOOT SWITCHING SIDE OF THE CABLE. THERE WAS NO INDICATION OF HARM TO PATIENTS OR USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863169 ↗
• MalfunctionJul 27, 2021Sparking; Sparking

  AN EM3-60 CABLE ADAPTER, WHICH IS CONNECTED TO AN ESU AND MONITORING DEVICE, DISPLAYED SMOKE AND SPARKS DURING A LAPAROSCOPIC ELECTROSURGICAL APPENDECTOMY PROCEDURE. POWER FROM THE ESU WAS SHUT OFF WHEN THE EVENT WAS DETECTED. NO PATIENTS OR USERS WERE HARMED DURING THIS EVENT OR AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233399 ↗
• MalfunctionSep 21, 2020Fire

  A TRANSFER CABLE USED IN ELECTROSURGERY HAD AN INSULATION BREACH WHICH RESULTED IN A VISIBLE FLAME. THIS IS THE THIRD TIME A CABLE HAS FAILED IN THE FIELD, THOUGH THIS IS THE ONLY ONE THAT RESULTED IN A FLAME. THIS FAILURE MODE IS BEING TRENDED. THE CABLE IS NON-PATIENT CONTACT, THE FAILURE RESULTED IN NO INJURIES ONLY A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10561301 ↗