BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METZ DEL CVD S/S 9

    MDR report key: 1193645 · Received July 25, 2008

    Report

    Report Number
    1226348-2008-00191
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LRW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT HAS BEEN NOTED THAT THIS COMPLAINT COULD NOT BE VERIFIED. THE CUSTOMER SUPPLIED 3 PHOTOGRAPHS OF THE SUBJECT SCISSORS. EVAL OF THE PHOTOGRAPHS REVEALED THAT THE TIP OF ONE SIDE OF THE JAW IS BROKEN. THE PHOTOGRAPHS DO NOT PROVIDE ADEQUATE DETAILS OF THE METAL SURFACE, THUS, IT IS NOT POSSIBLE TO FULLY EVALUATE THE BREAKAGE AREA/DAMAGE OR DETERMINE THE ROOT CAUSE OF BREAKAGE. SINCE THE PROD WAS NOT RETURNED AND NO LOT INFO WAS MADE AVAILABLE, IT IS NOT POSSIBLE TO FULLY IDENTIFY THE ROOT CAUSE OR TO EVALUATE MFG RECORDS FOR THE SUBJECT DEVICE BASED ON THE RESULTS OF THIS INVESTIGATION, NO CORRECTIVE ACTION OR F/U IS POSSIBLE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    CONTACT REPORTS THE SCISSORS WERE HANDED TO PHYSICIAN, WHEN HANDED BACK, THE TIP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METZ DEL CVD S/S 9 SCISSORS, GENERAL, SURGICAL LRW CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN