BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM 30 AUTOCLAVABLE LAPAROSCOPE

    MDR report key: 2842422 · Received October 22, 2012

    Report

    Report Number
    2936485-2012-00519
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 23, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K910132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE UNIT, IT WAS DETERMINED THAT A "MISSING KEEL TIP" FAILURE MODE WAS CONFIRMED AND WE ARE REPORTING AT THIS TIME. ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF THE UNIT, IT WAS OBSERVED THAT THE DISTAL END OF THE OPTIC IS DAMAGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK