BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 7882778 · Received September 17, 2018

    Report

    Report Number
    3005075853-2018-12813
    Event Type
    Injury
    Date Received
    September 17, 2018
    Report Date
    September 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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

    TITLE: COMPARISON OF BIPOLAR ELECTROSURGICAL DEVICES FOR USE IN GYNECOLOGIC LAPAROSCOPY. AUTHORS: GINN DN,1 SHIBER L-D,2 JAN AG,1 BISCETTE SM,1 GASKINS JT,3 BOWMAN BW,4 PASIC RP.1. CITATION: ABSTRACTS / JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2016; 23: S1¿S252 DOI: HTTPS://DOI.ORG/10.1016/J.JMIG.2016.08.101. THE OBJECTIVES OF THE STUDY WAS TO COMPARE 2 LAPAROSCOPIC BIPOLAR ELECTROSURGICAL DEVICES USED IN TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH). AN ARTICULATING ADVANCED ENSEAL BIPOLAR DEVICE (ETHICON) AND AN ELECTROTHERMAL BIPOLAR VESSEL SEALER WERE ANALYZED FOR DIFFERENCES IN SURGICAL OUTCOMES AND PERIOPERATIVE COMPLICATION RATES. A TOTAL OF 140 PATIENTS COMPLETED THE STUDY. OF WHICH, 70 PATIENTS (AGE: 41.6 ± 6.9 YEARS; BMI: 35.6 ± 10.1) WERE RANDOMIZED UNDER THE ENSEAL GROUP AND 70 PATIENTS WERE RANDOMIZED UNDER THE LIGASURE GROUP. IN THE ENSEAL GROUP, REPORTED COMPLICATIONS INCLUDED ANY COMPLICATIONS (N-1) AND DEVICE FAILURE (N-10). THE ARTICULATING ADVANCED BIPOLAR DEVICE WAS SHOWN TO HAVE A STATISTICALLY-SIGNIFICANT INCREASE IN SURGEON-PERCEIVED WORKLOAD AND RATE OF DEVICE FAILURE WHEN USED IN TLH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721070 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1