BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC GRASPER

    MDR report key: 303417 · Received November 6, 2000

    Report

    Report Number
    303417
    Event Type
    Other
    Date Received
    November 6, 2000
    Date of Event
    October 25, 2000
    Report Date
    November 6, 2000
    Manufacturer
    D & G PRESTIGE
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN OPERATING ROOM UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. THE ATRAUMETIC GRASPER, NON-DISPOSABLE BROKE AT THE DISTAL END. ONE PIECE FOUND OUTSIDE PT ON SURGICAL DRAPE AND A SECOND PIECE REMOVED FROM INSIDE PT. XRAY TAKEN FOR POSSIBLE RETAINED PIECE. XRAY NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC GRASPER NON-DISPOSABLE ENDOSCOPIC GRASPER GCJ D & G PRESTIGE 8360-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other