BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1621676 · Received February 5, 2010

    Report

    Report Number
    1621676
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 3, 2010
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADOLESCENT MALE WITH DISLOCATED THE PATELLA KNEE INJURY. MRI REVEALED MEDIAL RETINACULAR INJURY, INTRAARTICULAR LOOSE BODY AND RETROPATELLAR CARTILAGE INJURY. THE SHEATH ON THE NEW STORZ SCOPE AND TOWER SYSTEM EXTENDS BEYOND THE SCOPE CREATING A LIP. THE EDGE OF THE SHEATH SCRAPED THE CARTILAGE. EXTENDED TIME IN SURGERY. NOT SURE WHAT EFFECT THE SCRAPE WILL HAVE ON THE PATIENT'S OUTCOME. MANUFACTURER RESPONSE (AS PER REPORTER) FOR SINGLE PORT SHEATH, STORZ ENDOSCOPETHE MANUFACTURER HAS BEEN TRYING TO "RETOOL" THE SHEATH.ATTEMPTS HAVE BEEN UNSUCCESSFUL. DECISION TO SWITCH TO STORZ MADE BY ENDOSCOPY, ORTHOPEDIC USE HAS MANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ARTHROSCOPE, SHEATH HRX KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR NO OTHER THERAPIES