ERBE 20132-218Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04050147014022), received between Oct 13, 2017 and Sep 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Break

  FROM STAFF: MEDICAL DEVICE MALFUNCTION, ARGON PLASMA COAGULATOR TIP CAME OFF, FIAPC SONDE M. FILTER 2200C ITEM REF# 20132-218, LOT# 212660. THE TIP OF THE ARGON PLASMA COAGULATOR OFF VERY EASILY WHILE CLEANING IT. FOR REFERENCE, THE TIP OF THE COAGULATOR IS 1/4 THE SIZE OF AN AVERAGE PIN HEAD. SAID TIP CAME OFF WITH ITS WIRING WHILE CLEANING IT IN THE MIDDLE OF SURGERY. TIP IS CURRENTLY NOT INCLUDED IN THE SUBMITTED DEVICE BECAUSE THE SAID PART HAS TISSUE IN IT AND WAS BEST TO HAVE IT DISCARDED. AS SOON AS THE TIP WAS NOTICED TO HAVE COME OFF, DEVICE WAS PLUGGED OUT AND QUICKLY REPLACED WITH A NEW ONE. NO HARM WAS DONE DUE TO SAID INCIDENT BUT MAY POTENTIALLY PUT PATIENT AT RISK IF IT HAPPENS AGAIN INTRAOPERATIVELY WHILE DOING SAID COAGULATION IF IT MAY HAPPEN AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082969 ↗
• MalfunctionOct 13, 2017Detachment Of Device Component; Device Or Device Fragments Location Unknown

  THE CIRCUMFERENTIAL CAUTERY PROBE WAS PLACED IN THE PATIENT THROUGH ENTEROSCOPY SCOPE AND SEVERAL CAUTERY APPLICATIONS WERE DONE. THE PROBE WAS REMOVED AND THE TIP WAS WIPED DOWN PER PROCEDURE. THE PROBE WAS THEN PLACE IN THE SCOPE AGAIN. WHEN THE TIP WAS VISUALIZED, THE TIP OF THE PROBE WAS GONE. THE PROBE WAS REMOVED FROM THE FIELD AND GIVEN TO CLINICAL ENGINEERING. WHEN QUESTIONED FURTHER, THE AUTHOR OF THE INTERNAL REPORT STATED THAT THE SURGEON WAS SURE THE MISSING PORTION OF THE TIP DETACHED WHEN THE INSTRUMENT WAS BEING WIPED DOWN, AND THAT IT HAD NOT FALLEN IN THE PATIENT. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6947480 ↗