BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPOLAR FORCEPS, UNSPECIFIED

    MDR report key: 7507290 · Received May 11, 2018

    Report

    Report Number
    2523190-2018-00070
    Event Type
    Death
    Date Received
    May 11, 2018
    Report Date
    April 20, 2018
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBERS: 3006697299-2018-00025, 3006697299-2018-00026, AND 2523190-2018-00069. HTTPS://DOI.ORG/10.1016/J.HPB.2017.10.006.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNAVAILABLE, HENCE THE APPLICABLE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE COMPLAINT IS NOT CONFIRMED. AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    HPB (2018) PUBLISHED ¿FULLY LAPAROSCOPIC LEFT HEPATECTOMY-A TECHNICAL REFERENCE PROPOSED FOR STANDARD PRACTICE COMPARED TO THE OPEN APPROACH: A RETROSPECTIVE PROPENSITY SCORE MODEL¿ IN WHICH IT DISCUSSED THE SAFETY AND EFFECTIVENESS OF THE LAPAROSCOPIC LEFT HEMIHEPATECTOMY (LLH) TECHNIQUE DEVELOPED AT HENRI MONDOR HOSPITAL SINCE 1996. A SINGLE-SERIES, RETROSPECTIVE PAIR-MATCHED SAFETY/EFFICACY STUDY WAS PERFORMED, COMPARING (LLH) WITH OPEN LEFT HEMIHEPATECTOMY (OLH). THE ANALYSIS COVERED 17 LLH AND 51 OLH PERFORMED FROM 1996 TO 2014. FOR THE LLH, THREE COAGULATION DEVICES WERE UTILIZED: HARMONIC ACE (ULTRACISION, ETHICON ENDO-SURGERY), LIGASURE (COVIDIEN) AND A BIPOLAR FORCEPS (MICROFRANCE) AND ONE ULTRASONIC DISSECTOR (CUSA, INTEGRA). RESULTS: NO POSTOPERATIVE DEATH OCCURRED IN THE LLH GROUP WHILE THREE PATIENTS DIED IN THE OLH GROUP. CONCLUSION: THE TECHNIQUE IS RECOMMENDED AS A POSSIBLE TECHNICAL REFERENCE FOR STANDARD LLH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351628 BIPOLAR FORCEPS, UNSPECIFIED BIPOLAR FORCEPS GEI INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death HARMONIC ACE (ETHICON)| LIGASURE (COVIDIEN)