BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKLINE

    MDR report key: 11371911 · Received February 24, 2021

    Report

    Report Number
    11371911
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 12, 2021
    Manufacturer
    KARL STORZ IMAGING, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE SIDE OF A LAPAROSCOPIC FLAT BOWEL GRASPER BROKE OFF WHILE INSIDE OF THE PATIENT. ONE JAW OF GRASPER BROKE OFF. ALL PARTS REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270810 CLICKLINE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GEI KARL STORZ IMAGING, INC. 33410LF

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA