BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR CUTTING LOOP ELECTRODE, ROUND

    MDR report key: 2451076 · Received February 3, 2012

    Report

    Report Number
    1418479-2012-00001
    Event Type
    Other
    Date Received
    February 3, 2012
    Date of Event
    December 16, 2011
    Report Date
    February 1, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORP TRIED TO CONTACT THIS FACILITY NUMEROUS TIMES TO GATHER ADD'L INFO REGARDING DEVICE AND INTENDED PROCEDURE. THERE WAS NO RESPONSE FROM THE FACILITY (VERBALLY OR IN WRITING). REPORTS WERE REVIEWED, THIS FACILITY HAS REPORTED PROBLEMS WITH THIS DEVICE PREVIOUSLY. MDR1418479-2011-00022. EVENT DATE: (B)(6) 2011. DEVICE # 4622.133, LOT #:393111, EXP. 06/2016. PROCEDURE: HYSTEROSCOPIC MYOMECTOMY. MDR1418479-2012-00001. USER FACILITY DID NOT RETURN THE DEVICE FOR EVAL, THEREFORE, A FULL INVESTIGATION COULD NOT BE COMPLETED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS REGARDING HIGH TEMPERATURES AND IRRIGATION FLUID. RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, WE WILL SEND F/U INFO IF RECEIVED BY THE FACILITY.

    Description of Event or Problem · 1

    FACILITY HAS REPORTED THE FOLLOWING: THE WOLF LARGE LOOP ELECTRODE BROKE OUTSIDE OF PT AND WAS WITNESSES BY MD. TEAM WAS UNABLE TO FIND THE BROKEN PIECE ON THE FLOOR. PROCEDURE: HYSTEROSCOPIC MYOMECTOMY X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR CUTTING LOOP ELECTRODE, ROUND BIPOLAR ELECTRODE KNS RICHARD WOLF MEDICAL INSTRUMENTS CORP. 4622-133 450111

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other