BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE HARMONIC

    MDR report key: 3772260 · Received April 14, 2014

    Report

    Report Number
    3772260
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE HANDPIECE (REF#HAR36 LOT#K92U08) USED. GENERATOR (GENERATOR #11) INSTRUCTED OPERATOR TO RESTART GENERATOR. GENERATOR RESTARTED; SHORTLY AFTER HANDPIECE REACTIVATED AND USED, GENERATOR INSTRUCTED OPERATOR TO RESTART GENERATOR. GENERATOR THEN REPLACED WITH A DIFFERENT GENERATOR; HANDPIECE, CORD, AND NEW GENERATOR REASSEMBLED. GENERATOR PROCEEDED TO OCCASIONALLY ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228503 ACE HARMONIC ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSC GEI ETHICON ENDO SURGERY * K92U08
    228504 * ELECTROSURGICAL GENERATOR GEI ETHICON ENDO SURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR GENERATOR (GEN 11 - SN: (B)(4)) INSTRUCTED| OERATOR TO RESTART GENERATOR.