ERBE 20193-074Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04050147005167), received between Oct 21, 2020 and Dec 15, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Component Misassembled; Component Misassembled

  ON NOVEMBER 25TH, 2025 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION INVOLVING A MONITORING DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE]: "THE ELECTRODE [MONITORING DISPERSIVE ELECTRODE] MALFUNCTIONED. OUR CUSTOMER FOUND THE CAUSE. SEE IMAGE. PLEASE ANALYZE THE FAULT." WE ALSO HAVE RECEIVED A PICTURE SHOWING THA THE CABLE RING EYELET OF ONE ALUMINIUM AREA WAS NOT RIVETED AND WAS ONLY HELD IN PLACE BY THE ADHESIVE FOAM INSULATION AROUND THE CABLE CONNECTING AREA AT THE TOP SIDE OF THE MONITORING DISPERSIVE ELECTRODE. BECAUSE OF THIS THE CABLE TERMINAL WAS SO PLACED THAT IT TOUCHED BOTH ALUMINUM AREAS AND THUS SHORTING THEM. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800458 ↗
• MalfunctionFeb 18, 2025Component Misassembled; Component Misassembled

  ON JANUARY 30TH, 2025 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION INVOLVING A MONITORING DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE]: "CUSTOMERS NOTICED: NE [MONITORING DISPERSIVE ELECTRODE] IS IN TWO PARTS, BUT IS RECOGNIZED BY THE DEVICE AS ONE PART. CAN BE REPRODUCED ON HF DEVICE [GENERATOR]. (...) INSULATION AROUND ELECTRODE CONNECTING TAB REMOVED FOR ANALYSIS PURPOSES. CONACTING TAB OF ONE SIDE OF THE CONDUCTIVE [ALUMINUM] MATERIAL IS BENT IN CONTACT SURFACE [ELECTRODE CONNECTING TAB] AND IS ALSO CONNECTED TO THE OTHER SIDE OF THE CONDUCTIVE [ALUMINUM] MATERIAL BY A CRIMP CONTACT. (SHORT CIRCUIT)". NO FURTHER DETAILS HAVE BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394991 ↗
• MalfunctionSep 20, 2024No Apparent Adverse Event; Component Misassembled; No Apparent Adverse Event; Component Misassembled

  ON AUGUST 23ST, 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT UNKNOWN USER FACILITY. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY®PLATE 170 ZWEITEILIG (MODEL XL31A) AND AN UNKWNOWN GENERATOR HAVE BEEN USED. THE INITIAL REPORTER STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "THE INSULATION IS MISSING AT THE NESSY CONNECTION. THE CABLE CONNECTIONS ARE EXPOSED!" NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR DESPITE FURTHER REQUESTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272494 ↗
• MalfunctionMar 8, 2023Component Misassembled; Component Misassembled

  ON (B)(6) 2023, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN TO ENGLISH]: "THE COVER THAT SHOULD BE ON THE CONNECTOR IS MISSING. IT IS A COMPLAINT FROM AN END USER." ON (B)(6) 2023 WE HAVE RECEIVED THE CONCERNED CUSTOMER SAMPLE SHOWING THAT THE RIVET INSULATION ON THE NEUTRAL ELECTRODE NECK OF THE ATTACHED CABLE IS MISSING. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500814 ↗
• MalfunctionNov 2, 2022Component Misassembled; Component Misassembled

  ON (B)(6) 2022, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "THE CRIMP CONTACTS (RING EYELET) WERE BOTH INSERTED ON JUST ONE CONTACT SURFACE OF THE NESSY [ELECTRODE CONNECTING TA], WHICH MEANT THAT THE RESISTANCE VALUE WAS TOO LOW AND THE NESSY [ELECTRODE CONNECTING TA] COULD NOT BE USED. NORMALLY THERE SHOULD BE ONE CRIMP CONTACT PER ELECTRODE SIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713336 ↗
• MalfunctionOct 21, 2020Component Missing; Component Missing

  ON SEPTEMBER 24TH, 2020 WE HAVE BEEN INFORMED ABOUT A PRODUCT PROBLEM INVOLVING A DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A/1) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORTER STATED THAT UPON OPENING THE PACKAGE IT WAS FOUND THAT THE INSULATION AROUND RIVET AND CABLE TERMINAL WAS MISSING. THIS CAN LEAD TO BURNS DURING THE APPLICATION WITH A VERY HIGH PROBABILITY. NO FURTHER INFORMATION WAS PROVIDED TO US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10709973 ↗