BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE TWSITER

    MDR report key: 6101842 · Received November 15, 2016

    Report

    Report Number
    6101842
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ALTO DEVELOPMENT CORP.
    Product Code
    HXS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC SURGERY THE SURGEON WAS USING THE WIRE TWISTER WHEN A WASHER FELL OFF OF THE INSTRUMENT. THE WASHER WAS SUCCESSFULLY LOCATED IN THE SURGICAL DRAPES, RESULTING IN NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752411 WIRE TWSITER TWISTER, WIRE HXS ALTO DEVELOPMENT CORP. 05-500

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR