BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIED MEDICAL

    MDR report key: 1852937 · Received September 29, 2010

    Report

    Report Number
    MW5017650
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HUB OF DEVICE FELL APART AND BECAME TOTALLY INOPERATIVE AFTER INTRODUCTION INTO PATIENT. RESULTING IN DELAY OF SURGERY, AND PROLONGED ANESTHESIA. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: ACUTE APPENDICITIS => LAPAROSCOPIC APPENDECTOMY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLIED MEDICAL OPTICAL SEPARATOR SYSTEM W/UNIVERSAL SEAL HANDLED GCJ ASCENT HEALTHCARE SOLUTIONS C0124 1221630

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Disability STRYKER 1288 HD CAMERA WITH 30 DEGREE 5 MM| STRYKER SCOPE