BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE,22 FR CUTTING LOOP

    MDR report key: 4993356 · Received August 10, 2015

    Report

    Report Number
    1418479-2015-00023
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 23, 2015
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RWMIC FACILITY AS OF (B)(4) 2015. A REQUEST FOR ADD'L INFO AS WELL AS PHOTOS OF DEVICE SUBMITTED. NO RESPONSE AS OF (B)(4) 2015. TWO MOST LIKELY SCENARIOS ON HOW LOOP COULD HAVE BROKEN: TIP BENT; EXCESSIVE FORCE APPLIED OR TIP CAME INTO CONTACT W/HARD OBJECT., TIP OVER HEATED; EXTENDED USE OF DEVICE OR ACTIVATED WHILE OUTSIDE OF LIQUID OR WHEN "COAG" PEDAL, OT THE "CUT" PEDAL USED. 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. ONE SIMILAR EVENT HAS OCCURRED ON THIS DEVICE IN THE LAST THREE YEARS. LIKE THIS EVENT, BOTH DEVICES BROKE DURING SAME PROCEDURE. (MDRS #1418479-2013-00032 & 1418479-2013-00034). RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWMIC RECEIVE'S ADD'L INFO, A FOLLOW-UP REPORT W/BE PROVIDED TO FDA.

    Description of Event or Problem · 1

    RICHARD WOLF MED. INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDWATCH REPORT INDICATING LOOP OF TWO DEVICES BROKE OFF DURING A PROCEDURE AT THE FACILITY. NO INJURY TO PATIENT OR STAFF REPORTED. TIP OF DEVICE BROKE OFF AND FACILITY SWAPPED OUT TO BACK UP DEVICE, SAME DEVICE ID & LOT #. TIP OF BACK UP DEVICE ALSO BROKE OFF. PROCEDURE COMPLETED W/THIRD DEVICE. TWO MDRS WILL BE SUBMITTED FOR THIS EVENT. MDR #1418479-2015-0023 AND MDR#1418479-2015-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521704 ELECTRODE,22 FR CUTTING LOOP FAS RICHARD WOLF MEDICAL INSTRUMENTS CORP. 4622.253 51002763

    Patients

    Seq Age Sex Outcome Treatment
    1