BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1242413 · Received November 24, 2008

    Report

    Report Number
    3005075853-2008-03321
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/24/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC NISSEN PROCEDURE, THE PATIENT EXPERIENCED A SERIOUS POST OP BLEED FROM THE SPLENIC ARTERY. THE SURGEON DID NOT EXPERIENCE ANY INTRA OP COMPLICATIONS. IT WAS NOT REPORTED HOW THE BLEEDING WAS CORRECTED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE