E-LINE 8655384Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207059708), received between Oct 10, 2017 and Oct 10, 2017 — classified as 1 injury.

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

• InjuryOct 10, 2017Break; Detachment Of Device Component

  RICHARD WOLF MEDICAL INSTRUMENTS COOPERATION (RWMIC) WAS INFORMED BY ONE OF ITS SALES REPRESENTATIVES THAT DURING A PROCEDURE THE DEVICE IN QUESTION BROKE OFF INSIDE OF PATIENT. PROCEDURE COMPLETED AS SCHEDULED. NO INJURY TO PATIENT OR STAFF REPORTED. DEVICE APPROXIMATELY (B)(4) YEARS OLD. FACILITY HAS BEEN CONTACTED, VIA PHONE AND EMAIL, IN AN EFFORT TO GATHER ADDITIONAL/MISSING FOR MEDWATCH REPORT. NO RESPONSE RECEIVED AS OF (B)(6) 2017. THERE HAVE BEEN TWO SIMILAR COMPLAINTS HAVE BEEN REPORTED LAST THREE YEARS (MDR 1418479-2015-0027 AND 1418479-2015-00029). INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: 7 USE CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER THE PATIENT. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. MAKE SURE THAT NO MISSING PARTS REMAIN IN THE PATIENT. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. 7.2.5 HF APPLICATION WARNING! ACTIVATE HF INSTRUMENTS ONLY AFTER THE LIVE PART CONDUCTING HF CURRENT HAS BECOME FULLY VISIBLE IN THE FIELD OF VIEW OF THE ENDOSCOPE AND TOUCHES THE INTENDED AREA TO BE T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6935719 ↗