BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM

    MDR report key: 2913036 · Received January 8, 2013

    Report

    Report Number
    2027111-2013-00004
    Date Received
    January 8, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 8, 2013
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 CHOL- "THE JAW DID NOT OPEN. THE CHOLBLADDER WAS IN BETWEEN THE JAWS." PATIENT STATUS- " PATIENT IS OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10416 EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM NONE GCJ APPLIED MEDICAL RESOURCES CORP. C4130 1176616

    Patients

    Seq Age Sex Outcome Treatment
    1