BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAPROSCOPIC BOWEL GRASPER

    MDR report key: 5656427 · Received May 11, 2016

    Report

    Report Number
    MW5062254
    Event Type
    Other
    Date Received
    May 11, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 11, 2016
    Manufacturer
    KARL STORZ ENDOSCOPY - AMERICA, INC.
    Product Code
    GCJ
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PIECE OF A LAPAROSCOPIC BOWEL GRASPER BROKE OFF WHILE INSIDE THE PATIENT'S ABDOMEN. THE BROKEN PIECE OF GRASPER WAS KEPT UNDER DIRECT VISUALIZATION AND ANOTHER INSTRUMENT WAS PLACED TO REMOVE IT. THE BROKEN PIECE WAS REMOVED WITHOUT INCIDENT THROUGH THE 8MM PORT. DIAGNOSIS OR REASON FOR USE: RIGHT LOWER QUADRANT PAIN AND SUSPECTED SPONTANEOUS ABORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302730 LAPROSCOPIC BOWEL GRASPER LAPROSCOPIC BOWEL GRASPER GCJ KARL STORZ ENDOSCOPY - AMERICA, INC. 33310C

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR