E-LINE 8654224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207018736), received between Aug 7, 2017 and Jul 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 15, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON (B)(6) 2020 THE USER FACILITY REPORTED THE FOLLOWING TO RWMIC: THE WORKING ELEMENT WAS BURNED DURING A CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276320 ↗
• MalfunctionAug 7, 2017Arcing of Electrodes; Sparking; Arcing of Electrodes; Sparking

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY A COMPANY REPRESENTATIVE THAT DURING A PROCEDURE A SPARK WAS SEEN. NO ILLNESS / INJURY WERE REPORT AND THERE WERE NO DELAYS IN THE PROCEDURE WHICH PUT THE PATIENT AT RISK. BACK UP DEVICE AVAILABLE FOR USE AND PROCEDURE WAS COMPLETED AS SCHEDULED. INITIAL REPORTER HAS BEEN CONTACTED, VIA EMAIL, IN EFFORTS TO GATHER REQUIRED MEDWATCH INFORMATION. RWMIC HAS NOT RECEIVED A RESPONSE AS OF 08/07/2017. MANUFACTURE DATE: DEC2012. PURCHASE DATE: (B)(6) 2013. SERVICE DATES: NONE ON RECORD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6771713 ↗