BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM DORSEY GRASPER

    MDR report key: 2900111 · Received December 27, 2012

    Report

    Report Number
    2936485-2012-00564
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE JAW BROKE AND CAME OFF. IT WAS FURTHER REPORTED THAT THE BROKEN TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM, 33CM DORSEY GRASPER KOG STRYKER ENDOSCOPY SAN JOSE 383699

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK