BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM 30 DEGREE AUTOCLAVABLE LAPAROSCOPE

    MDR report key: 2051819 · Received March 15, 2011

    Report

    Report Number
    2936485-2011-00154
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. A SECOND SIMILAR UNIT WITH (B)(4) WAS ALSO IMPLICATED IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS ON EACH UNIT WAS FALLING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM 30 DEGREE AUTOCLAVABLE LAPAROSCOPE LAPAROSCOPE GCJ STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK