BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIS SUPERCUT SCISSOR

    MDR report key: 1962982 · Received January 6, 2011

    Report

    Report Number
    1962982
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AESCULAP, INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE MD NOTED MISSING TIP FROM SCISSORS. MD REMOVED THE TIP FROM PATIENT'S LEFT EAR WITHOUT PATIENT HARM. THESE SCISSORS ARE PEEL PACKED INDIVIDUALLY. THEY WERE ONLY PURCHASED TWO MONTHS PRIOR TO USE. THEY ARE DOUBLE PEEL PACKED, BUT PRIOR TO PACKING THEM THE TIPS HAVE INSTRUMENT PROTECTORS ON THEM. THEY WERE STERILIZED UNDER THE MANUFACTURER'S STANDARD RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIS SUPERCUT SCISSOR SCISSORS, SURGICAL LRW AESCULAP, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR