BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJ GRASPER 5MM

    MDR report key: 273654 · Received April 14, 2000

    Report

    Report Number
    1038548-2000-00001
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    November 11, 1999
    Report Date
    February 23, 2000
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GALL BLADDER PROCEDURE, THE COMPLAINANT ALLEGED THAT THEY OBSERVED A PIECE OF THE INSTRUMENT LYING ON THE FLOOR OF THE ABDOMEN WHERE THE GRASPER WAS BEING USED TO GRASP. THE INSTRUMENT PIECE WAS REMOVED AND RETURNED TO "GSP" FOR EVAL AND TO ENSURE THAT ALL PARTS WERE PRESENT. THE PHYSICIAN PERFORMED AN X-RAY TO ENSURE NO PARTS REMAINED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DJ GRASPER 5MM GRASPER GCJ GENZYME SURGICAL PRODUCTS CORP. NA C99

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention