E-LINE 8654204Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207018712), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Temperature Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2019Temperature Problem; Temperature Problem

  ON NOVEMBER 07, 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A REPORT FROM RICHARD WOLF (B)(4) INVOLVING THE FOLLOWING DEVICES: 815.052 LOT 523/573 (MDR 9611102-2018-00015), 815.032 LOT 006/086 (MDR 9611102-2018-00016), 8674.205 LOT 1259038 (MDR 9611102-2018-00017), 8680.205 LOT 1255367 (MDR 9611102-2018-00018), 8654.204 LOT 1202777 (THIS MDR). IT WAS REPORTED THAT THE PATIENT SUFFERED THIRD DEGREE BURN ON THE RIGHT FINGER DUE TO HF APPLICATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSPECTION SHOWED THAT THE CAUSE OF THE FAULT DESCRIBED BY THE USER CANNOT BE TRACED BACK TO THE WORKING ELEMENTS OR HF CONNECTION CABLE MONO. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. NO DEFECTS WERE FOUND IN THE MEDICAL DEVICES. IN CONCLUSION, THE COMBUSTION WAS NOT CAUSED BY A FAULTY HF DEVICE OR ACCESSORY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8363755 ↗