BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 8160287 · Received December 13, 2018

    Report

    Report Number
    3005075853-2018-15074
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    January 1, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036015055
    PMA / PMN Number
    K160752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MDR DECISION IS NOW NOT REPORTABLE AS THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ADDITIONAL INFORMATION RECEIVED FROM JJM REP VIA EMAIL: "THE CASE WAS CONVERTED TO OPEN NOT DUE TO HARMONIC FAILURE. PATIENT WAS NOT HARMED DUE TO FAILURE. POST OP AS PER NORMAL OPEN PROCEDURES." UPON REVIEW OF THE ADDITIONAL INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CONVERTED TO OPEN HIGH ANTERIOR RESECTION WITH ILEOSTOMY FORMATION, THE DEVICE STOPPED WORKING, "WOULDN¿T CLEAN." THE MACHINE WAS TURNED ON/OFF TO TRY AGAIN, BUT AS A RESULT SAID "REPLACE INSTRUMENT." THE PATIENT WAS NOT HARMED AND THE CASE WAS CONTINUED WITHOUT ADVANCED ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999115 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036015055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR| GENERATOR