BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOKWALTER TILT RATCHET MECHANISM

    MDR report key: 605003 · Received May 19, 2005

    Report

    Report Number
    1226348-2005-00117
    Event Type
    Injury
    Date Received
    May 19, 2005
    Date of Event
    September 16, 2004
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FFO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004: DURING OPEN CHOLECYSTECTOMY, WHILE ASSEMBLING BOOKWALTER RETRACTOR (AT BEGINNING OF CASE), A PIECE BROKE OFF OF AN ADJUSTABLE RATCHET. THE ARM OR RATCHET WAS ACCOUNTED FOR BUT THE HEAD OF THE SCREW OR RIVET THAT SECURED IT TO THE RATCHET IS UNACCOUNTED FOR. THE MISSING PIECE IS APPROX 1-1.5 MM DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOKWALTER TILT RATCHET MECHANISM RETRACTOR, SELF-RETAINING FFO CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention