BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN BIOSURGICAL

    MDR report key: 11903185 · Received May 28, 2021

    Report

    Report Number
    3014527682-2021-00006
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 28, 2021
    Manufacturer
    AMERICAN BIOSURGICAL, LLC
    Product Code
    GEI
    UDI-DI
    10852028007021
    PMA / PMN Number
    K953889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROI CPS, LLC RECEIVED THE INFORMATION RELATED TO THIS REPORT THROUGH A CUSTOMER COMPLAINT. ROI CPS, LLC IS A PROCEDURE KIT MANUFACTURER. THE REPORTED DEVICE IS CONTAINED, AS A COMPONENT, WITHIN ROI KIT 800756004, LOT NUMBER 87847D. THE INCIDENT WAS REPORTED TO THE MANUFACTURER OF THE BIPOLAR CORD.

    Description of Event or Problem · 1

    THE PATIENT HAS A PACEMAKER SO THE BIPOLAR SHOULD NOT INTERFERE WITH ITS FUNCTION. WHEN THE SURGEON USED THE BIPOLAR, THE PATIENT STARTED HAVING ARRHYTHMIAS. THE SURGEON DISCONTINUED USING IT, SWITCHED TO A DIFFERENT BIPOLAR CORD AND NO FURTHER ARRHYTHMIAS WERE NOTED. WE ARE NOT SURE IF THE CORD WAS RESPONSIBLE, BUT IT IS SUSPICIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801761 AMERICAN BIOSURGICAL BIPOLAR CORD 12FT DISP CLEAR NS GEI AMERICAN BIOSURGICAL, LLC AB 1000-C-NS 2020030025 10852028007021

    Patients

    Seq Age Sex Outcome Treatment
    1