ERBE 20193-072Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04050147005143), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ON JUNE 21ST, 2022, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT UNIVERSITY HOSPITAL (B)(6). A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A/1) AND AN ABLATION DEVICE HAT 500 GENERATOR WERE USED. THE PROCEDURE LASTED FOR 164 MINUTES. THE INITIAL REPORTER STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "DURING ELECTROPHYSIOLOGICAL PROCEDURE WITH ABLATION TREATMENT USING RADIOFREQUENCY CURRENT, UNEXPECTED BURNS OCCURRED IN THE AREA OF THE NEUTRAL ELECTRODE. AFTER REMOVAL, THE BURNS ON THE EDGE OF THE ELECTRODE BECAME VISIBLE AND WERE TREATED IMMEDIATELY, AND A CORRESPONDING CONSULTATION REQUEST WAS MADE TO THE COLLEAGUES IN TRAUMA SURGERY. IT WAS AN UNCOMPLICATED REGULAR PROCEDURE WITHOUT SIGNIFICANT ABNORMALITIES. EVEN IN THE FOLLOW-UP INSPECTION, NO ACCUMULATIONS OF LIQUID, INCORRECTLY CONNECTED CABLES OR OBVIOUS DEFECTS IN THE DEVICES COULD BE FOUND. THE AFFECTED NEUTRAL ELECTRODE (INCLUDING CABLE) WAS SECURED AND KEPT SAFE. NO OBVIOUS MATERIAL DEFECT COULD BE IDENTIFIED. THE ABLATION INCLUDING SCLEROTIZATION OF THE ADDITIONAL PATHWAY WAS SUCCESSFUL. THE FOLLOWING PRODUCTS HAVE BEEN USED FOR THE PROCEDURE: ABLATI

  Patient problems: Burn(s)

  MAUDE report 14984099 ↗