BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM

    MDR report key: 2941657 · Received January 18, 2013

    Report

    Report Number
    2027111-2013-00010
    Date Received
    January 18, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 18, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 ADDITIONAL INFORMATION 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

    LAPAROSCOPIC PROCEDURE FOR SIGMOID RESECTION WITH COLORECTAL ANASTOMOSIS AND MOBILIZATION OF SPLENIC FLEXURE. THE PROXIMAL OCCLUSION WAS PERFORMED USING THE LAPAROSCOPIC GRASPER IN CONJUNCTION WITH A FLEXIBLE SIGMOIDOSCOPY OF THE ANASTOMOSIS. AFTER THE GRASPER WAS REMOVED, IT WAS DETERMINED THAT A SMALL SECTION FROM THE TIP OF THE GRASPER WAS MISSING. THE PIECE WAS FOUND INSIDE THE TROCAR AND REMOVED. THE GRASPER WAS COMPARED TO A NEW GRASPER AND DETERMINED THAT ALL PIECES HAD BEEN RETRIEVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28413 EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM NONE GCJ APPLIED MEDICAL C4130 TBD

    Patients

    Seq Age Sex Outcome Treatment
    1