BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATERN/WALLER

    MDR report key: 838496 · Received April 5, 2007

    Report

    Report Number
    838496
    Event Type
    Malfunction
    Date Received
    April 5, 2007
    Date of Event
    April 2, 2007
    Report Date
    April 4, 2007
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ERGONOMIC MULTI-FUNCTIONAL HANDLE YELLOW TRIGGER BUTTON FELL OFF DURING PROCEDURE (LAPAROSCOPIC ASSISTED LOW ANTERIOR RESECTION). THIS HAND PIECE HAS BEEN SENT BACK TO THE MANUFACTURER TWICE, BOTH TIMES WITH ASSURANCES IT WAS FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATERN/WALLER ERGONOMINC MULTIFUNCTIONAL HANDLE GDZ KARL STORZ ENDOSCOPY-AMERICA, INC. 33124K *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR