BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM

    MDR report key: 2948272 · Received February 4, 2013

    Report

    Report Number
    2027111-2013-00035
    Event Type
    Other
    Date Received
    February 4, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 4, 2013
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56. IF WE OBTAIN ADD¿L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED. THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE ¿ ¿(B)(6) USING ITEM. PIECE OF MECHANISM CAME OFF. GRASPER LOCKED ON ORGAN. ITEM CAME AWAY WITH SMALL AMOUNT OF TISSUE STILL IN JAW. REPORT FROM CUSTOMER: LOCKING MECHANISM FELL AWAY FROM THE GRASPER LEAVING IT IN A LOCKED POSITION ON AN ORGAN. GRASPER RETRIEVED SAFELY BUT WITH SMALL AMOUNT OF ORGAN TISSUE STILL ATTACHED AND UNABLE TO RELEASE IT. GRASPER IS THEREFORE CONTAMINATED AND SEALED IN A CLINICAL WASTE BAG.¿ PATIENT STATUS: ¿NORMAL¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47251 EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM NONE GCJ APPLIED MEDICAL RESOURCES CORP. C4130 1162503

    Patients

    Seq Age Sex Outcome Treatment
    1