BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM SINGLE ACTION ATRAUMATIC GRASPER

    MDR report key: 1963291 · Received January 6, 2011

    Report

    Report Number
    2936485-2011-00010
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER 5MM, 33CM SINGLE ACTION ATRAUMATIC GRASPER FAILED DURING A LAP CHOLE CASE. IT WAS ALLEGED THAT DURING THE CASE, THE JAW HINGE FELL APART AND WENT INTO THE PT'S ABDOMEN. IT WAS FURTHER REPORTED THAT THE DOCTOR USED A TYPE OF GRASPER TO RETRIEVE THE PART OF THE JAW INSIDE THE ABDOMEN. ALSO, IT WAS FURTHER REPORTED THAT THE DOCTOR HAD TO USE A C-ARM (TYPE OF X-RAY) TO LOCATE THE ITEM AND IT TOOK ABOUT 30 MINUTES TO REMOVE OUT OF THE ABDOMEN. IT WAS REPORTED THAT THE PT'S PROCEDURE WAS COMPLETED SUCCESSFULLY AND AT THIS TIME, THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM, 33CM SINGLE ACTION ATRAUMATIC GRASPER GRASPER GCJ STRYKER ENDOSCOPY SAN JOSE 1043453

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK