BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIS GRIPPER

    MDR report key: 6099394 · Received November 14, 2016

    Report

    Report Number
    6099394
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    September 3, 2016
    Report Date
    September 16, 2016
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE "LEGS" OF AN ALLIS GRIPPER BROKE WHILE BEING USED. THE BROKEN PIECE WAS LOCATED AND REMOVED FROM PATIENT AND SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751566 ALLIS GRIPPER FORCEPS, GENERAL & PLASTIC SURGERY GEN AESCULAP IMPLANT SYSTEMS, LLC EA015R

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR