BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWEL GRASPER-ROBOTIC

    MDR report key: 1990006 · Received February 9, 2011

    Report

    Report Number
    MW5019386
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 9, 2011
    Manufacturer
    KARL STORZ ENDOSCOPY- AMERICA
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC DAVINCI HYSTERECTOMY, BOWEL GRASPER JAW BROKE OFF. UNABLE TO LOCATE DESPITE VISUALIZATION AND F/U FILM. DIFFICULT TO OBTAIN ADEQUATE FILM D/T SIZE. SECOND GRASPER USED AND A SECOND JAW BROKE, HOWEVER, WAS FOUND W/O ISSUE. DC HOME ON POD 2-3 BUT READMITTED WITH WOUND INFECTION AND RECTO-VAGINAL FISTULA. DURING CT SCAN, JAW NOTED IN PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOWEL GRASPER-ROBOTIC BOWEL GRASPER-ROBOTIC GCJ KARL STORZ ENDOSCOPY- AMERICA CEO123 DB2/03

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization