BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, CUTTING LOOP, 26FR

    MDR report key: 4953292 · Received July 27, 2015

    Report

    Report Number
    1418479-2015-00021
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Report Date
    June 29, 2015
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RWMIC FACILITY ON (B)(6) 2015. A REQUEST FOR ADD'L INFO AS WELL AS PHOTOS OF DEVICE SUBMITTED. NO RESPONSE AS OF (B)(6) 2015. DEVICE MANUFACTURED FEB 2015. THE TWO MOST COMMON SCENARIOS ON HOW TIP COULD HAVE BROKEN OFF IS AS FOLLOWS: TIP BENT (EXCESSIVE FORCE APPLIED OR TIP CAME INTO CONTACT W/HARD OBJECT), TIP OVERHEATED (EXTENDED USE OF DEVICE OR ACTIVATED WHILE OUTSIDE OF LIQUID). NOT UNCOMMON FOR TIP TO DISAPPEAR OR VAPORIZE WHEN THIS SCENARIO OCCURS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, I. E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS REGARDING HIGH TEMPERATURES AND USE OF IRRIGATION FLUID. NO SIMILAR ISSUES HAS OCCURRED ON THIS DEVICE IN THE LAST THREE YEARS. RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWMIC RECEIVES ADD'L INFO, A FOLLOW-UP WILL BE PROVIDED TO FDA.

    Description of Event or Problem · 1

    RICHARD WOLF MED. INSTRUMENTS CORP. (RWMIC) WAS RECENTLY NOTIFIED BY FACILITY WHICH REPORTED A PORTION OF DEVICE BROKE OFF AND FELL INTO PATIENT. THE FOREIGN OBJECT WAS EASILY RETRIEVED AND PROCEDURE COMPLETED AS SCHEDULED. NO INJURY TO PATIENT OR STAFF REPORTED. TOP OF DEVICE BROKE OFF AND FACILITY SWAPPED OUT TO BACK UP DEVICE, SAME DEVICE ID AND LOT NUMBER. TIP OF BACK UP DEVICE ALSO BROKE OFF. PROCEDURE COMPLETED W/THIRD DEVICE. TWO MDRS WILL BE SUBMITTED FOR THIS EVENT. REF MDR #1418479-2015-00020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485721 ELECTRODE, CUTTING LOOP, 26FR FAS RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8426.1420 51002653

    Patients

    Seq Age Sex Outcome Treatment
    1